M/L-10 1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00811099010388), received between Jun 1, 2018 and Oct 1, 2024 — classified as 20 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SAE WAS DESCRIBED AS A "CHRONIC LITHIASIS CHOLECYSTITIS (WITH MARKED EPITHELIAL DENUDATION)" AND ITS ONSET DATE WAS (B)(6) 2023. THE SUBJECT IS A 60-YEAR-OLD MALE WHO UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY (GENERAL SURGERY), PLACING 6 CLIPS IN BLOOD VESSELS AND THE BILE DUCT, ON (B)(6) 2023. ON (B)(6) 2023, DURING THE 30-DAY FOLLOW-UP VISIT OF THE STUDY, THE SUBJECT MANIFESTED PAIN AND DISCOMFORT DUE TO THE ACCUMULATION OF GALLSTONES BECAUSE OF THE PREVIOUSLY DIAGNOSED PATHOLOGY (CHRONIC LITHIASIS CHOLECYSTITIS), AFTER BEING CONFIRMED BY AN ABDOMINAL ULTRASOUND. THE SUBJECT WAS THEN PROGRAMMED FOR THE SURGICAL REMOVAL OF THE GALLBLADDER ON (B)(6) 2023. ACCORDING TO THE INVESTIGATOR´S CRITERIA, THE SAE HAS BEEN DETERMINED TO BE NOT RELATED TO THE PROCEDURE, NOT RELATED TO THE INVESTIGATIONAL DEVICE, AND NOT RELATED TO LEAKAGE, BY THE HOSPITAL TEAM. THIS CHOLECYSTITIS WAS THEN TREATED AND RESOLVED ON (B)(6) 2023 WITH A CHOLECYSTECTOMY.

  Patient problems: Unspecified Hepatic or Biliary Problem

  MAUDE report 20348699 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SAE ONSET WAS ON (B)(6) 2024 BUT THE SITE BECAME AWARE OF THE EVENT ON 13JUN2024. THE SAE HAS BEEN DESCRIBED AS "PERINEAL WOUND DEHISCENCE". THE SUBJECT IS A 78-YEAR-OLD WHO UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2024. ON (B)(6) 2024 THE SUBJECT SUFFERED A DEHISCENCE OF THE SURGICAL WOUND THAT PRESENTED GOOD APPEARANCE, IT WAS DRY AND WITHOUT SUPPURATION. SHE WAS INTERVENED BY THE FRIEDERICH TECHNIQUE ON 17FEB2024 AND WAS THEN DISCHARGED ON (B)(6) 2024. ACCORDING TO THE INVESTIGATOR´S CRITERIA, THE SAE HAS BEEN DETERMINED TO BE NOT RELATED TO NEITHER THE PROCEDURE OR THE DEVICE.

  Patient problems: Impaired Healing

  MAUDE report 19538985 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2024 BUT THE SITE BECAME AWARE OF THE EVENT ON 01JUN2024 DURING THE SUBJECT'S 6-MONTHS FOLLOW-UP, AND DID NOT CONSIDER THE EVENT AS SERIOUS UNTIL 06JUN2024. THE SAE HAS BEEN DESCRIBED AS "INTESTINAL OCCLUSION DUE TO INTERNAL HERNIA". THE SUBJECT IS A 60-YEAR-OLD MALE WHO UNDERWENT A LAPAROSCOPIC CYSTECTOMY DUE TO A CARCINOMA ON (B)(6) 2023. ON (B)(6) 2024 THE SUBJECT SUFFERED AN EPISODE OF BOWEL OCCLUSION DUE TO AN INTERNAL HERNIA THAT WAS CONFIRMED WITH A CT SCAN ON (B)(6) 2024 "SIGNS OF INTESTINAL OBSTRUCTION DUE TO PROBABLE INTERNAL HERNIATION OF LOOPS INTO THE PELVIC CAVITY W/ INTESTINAL ISCHEMIA". THE FOLLOWING DAY, ON (B)(6) 2024, AN EXPLORATORY LAPAROTOMY INVOLVING A SEGMENTAL ENTERECTOMY WITH L-L ANASTOMOSIS AND THE PLACEMENT OF A DRAIN WAS PERFORMED. DUE TO THE GOOD PERI AND POSTOPERATIVE EVOLUTION, HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. ACCORDING TO THE INVESTIGATOR´S CRITERIA, THE SAE HAS BEEN DETERMINED TO BE NOT RELATED TO NEITHER THE PROCEDURE OR THE DEVICE.

  Patient problems: Hernia

  MAUDE report 19505196 ↗
• MalfunctionApr 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR NOTICED SOME BLEEDING FROM THE ARTERY AFTER USING ML CLIP 1122 LOT 00169964. OPERATION WAS CHOLECYSTECTOMY. SEVERAL CLIPS WERE USED AND THE SAME PROBLEM WAS NOTICED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19213716 ↗
• MalfunctionMar 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) 2024: OPERATION CHOLECYSTECTOMY WENT WELL, THE PATIENT WENT HOME AND EVERYTHING WAS OK (B)(6) 2024: THE PATIENT WAS RE-OPERATED AND ARTERIAL LEAKAGE WAS FOUND. THE PATIENT IS DOING WELL. HE IS AT HOME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18969388 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT IS A 45-YEAR-OLD MALE WHO UNDERWENT A RIGHT HEMICOLECTOMY DUE TO A DOUBLE ADENOCARCINOMA OF THE RIGHT (STAGE II) AND SIGMOID (STAGE I) COLON ON (B)(6) 2024. THE SUBJECT HAD TAKEN A SECOND CYCLE OF XELOX (CAPECITABINE + OXALIPLATIN) ON (B)(6) 2024. ON (B)(6) 2024 HE WENT TO THE EMERGENCY ROOM AFTER ORAL INTOLERANCE, NAUSEA, VOMITING, DIARRHEA, AND MILD FEVER (37.5ºC). DURING THE EXPLORATION, THE PHYSICIANS OBSERVED ALSO AN ELEVATION OF THE ACUTE PHASE REACTANTS AND HYPERBILIRUBINEMIA, ALTHOUGH AN ABDOMINAL ECHOGRAPHY DID NOT SHOW ANY BLADDER OR LIVER PATHOLOGIC FINDINGS. THE SUSPECTED DIAGNOSIS WAS AN ABDOMINAL INFECTION THAT IS BEING TREATED WITH LEVOFLOXACIN + METRONIDAZOLE. AS OF TODAY, THE EVENT IS STILL CONSIDERED ONGOING.

  Patient problems: Sepsis

  MAUDE report 18907252 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 26FEB2024 WE WERE INFORMED OF A NEW SAE THAT HAS BEEN REPORTED AT SITE 06 (B)(6). THE DATE OF THE SAE ONSET WAS ON (B)(6) 2024. THE SITE BECAME AWARE OF THE EVENT ON 26FEB2024. THE SAE HAS BEEN DESCRIBED AS AN "ANASTOMOTIC LEAK". THE SUBJECT IS A 70-YEAR-OLD MALE WHO UNDERWENT A RIGHT HEMICOLECTOMY EXTENDED BY LAPAROSCOPY DUE TO COLON NEOPLASIA ON (B)(6) 2024. DURING THE PROCEDURE, AN INTRACORPOREAL ILIO-COLIC ANASTOMOSIS WAS PERFORMED. ON (B)(6) 2024 THE SUBJECT WENT TO THE EMERGENCY ROOM BECAUSE HE WAS EXPERIENCING ABUNDANT AND PURULENT EXUDATE THROUGH THE INSERTION POINT OF THE ABDOMINAL DRAIN. THE DRAIN HAD BEEN REMOVED THREE DAYS EARLIER. DURING THE MEDICAL EXAMINATION, THE PHYSICIANS DETECTED SUGGESTIVE FINDINGS OF AN ANASTOMOTIC DEHISCENCE OF THE ILEOCOLIC STUMP. FOR THE TIME BEING, CONSIDERING THE GOOD CONDITION OF THE SUBJECT, HE IS ONLY UNDER ANTIBIOTIC TREATMENT WITHIN THE HOSPITAL. THE EVENT IS CONSIDERED TO BE STILL ONGOING.

  Patient problems: Rectal Anastomotic Leakage

  MAUDE report 18788312 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT TODAY (B)(6) 2024). THE SUBJECT AFFECTED IS SUBJECT ES-006-057. THE SUBJECT PRESENTED A RECTAL NEOPLASIA, SO IT WAS DECIDED TO UNDERGO A ROBOTIC ANTERIOR RECTAL RESECTION THAT REQUIRED A COLORECTAL ANASTOMOSIS ON (B)(6) 2023. THREE DAYS AFTER, ON (B)(6) 2023, THE SITE TEAM NOTICED THAT THERE WAS SCARCE FECALOID CONTENT, AIR BY THE DRAINAGE PERIANASTOMOTIC ROOF, AND NO SIGNS OF PERITONEAL IRRITATION. THUS, IT WAS DECIDED TO PERFORM AN EMERGENCY SURGERY TO PERFORM AN ILEOSTOMY AND IRRIGATION. DURING THE SURGERY, IT WAS NOTICED A LEAK FROM A DEHISCENCE OF THE COLORECTAL ANASTOMOSIS PERFORMED DURING THE FIRST PROCEDURE AND POSTOPERATIVE PARALYTIC ILEUS, THEREFORE A PROTECTIVE ILEOSTOMY WAS PERFORMED. AS OF TODAY, THE SUBJECT IS STILL HOSPITALIZED. THE TOTAL TIME OF ADMISSION IS 16 DAYS.

  Patient problems: Rectal Anastomotic Leakage

  MAUDE report 18469694 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, REPORTING THIS INFORMATION TO US ON (B)(6) 2023 DURING THE EVENING. DURING THIS TIME WE HAVE BEEN REQUESTING ADDITIONAL INFORMATION FROM THE SITE AS THE INFORMATION PROVIDED IN THE EDC CASTOR WAS INSUFFICIENT. THE REPORTED SAE HAS BEEN DESCRIBED AS "BLEEDING IN THE SURGICAL FIELD, WITH HEMODINAMIC INESTABILITY." WHICH CAUSED A LIFE-THREATENING ILLNESS OR INJURY. THIS EVENT TOOK PLACE DURING THE PROCEDURE. THE SUBJECT IS A 46-YEAR-OLD FEMALE PATIENT. ON (B)(6) 2023 SHE UNDERWENT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 FOR A RIGHT DISTAL URETHRAL STRICTURE. A RIGHT URETHRAL REIMPLANTATION WAS PERFORMED. AFTER THE INTERVENTION, A HAEMORRHAGE WAS OBSERVED IN THE RIGHT ILIAC FOSSA. IT WAS DECIDED TO REOPERATE THE SUBJECT. AN EXPLORATORY LAPAROSCOPY WAS PERFORMED. THE HAEMORRHAGE WAS RESOLVED AFTER THE RE-INTERVENTION, SO THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2023.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18364261 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON 1NOV2023, REPORTING THIS INFORMATION TO US ON 15DEC2023 DURING THE EVENING. DURING THIS TIME WE HAVE BEEN REQUESTING ADDITIONAL INFORMATION FROM THE SITE AS THE INFORMATION PROVIDED IN THE EDC CASTOR WAS INSUFFICIENT. THE REPORTED SAE HAS BEEN DESCRIBED AS SELF-LIMITING RECTORRHAGIA WHICH PROLONGED AN EXISTING HOSPITALIZATION. THE SUBJECT IS A 83-YEAR-OLD FEMALE PATIENT. ON (B)(6) 2023 SHE UNDERWENT A DORSOVENTRAL RIGHT HEMICOLECTOMY DUE TO A NEOFORMATION OF THE CECUM. POSTOPERATIVE PERIOD WAS FAVORABLE AND SHE WAS DISCHARGED HOME ON (B)(6) 2023. ON (B)(6) 2023 SHE RETURNED TO THE EMERGENCY DEPARTMENT DUE TO A STOOL WITH FRESH BLOOD. SHE REPORTED NO ABDOMINAL PAIN NOR HAEMODYNAMIC INSTABILITY. A DIAGNOSIS OF RECTORRHAGIA WAS MADE. IT WAS DECIDED TO SUSPEND THE ANTICOAGULANT TREATMENT, AND START A SERUM THERAPY TREATMENT, INTRAVENOUS ANALGESIA AND FASTING. THE INCIDENT WAS RESOLVED WITH MEDICATION AND SHE WAS DISCHARGED ON (B)(6) 2023. THE EVENT WAS CONSIDERED RESOLVED ON 2NOV2023.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18364247 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, REPORTING THIS INFORMATION TO US YESTERDAY DURING THE EVENING. THE REPORTED SAE HAS BEEN DESCRIBED AS URETHRAL FISTULA DUE TO EXTREME PROXIMITY TO THE TUMOR WHICH PROLONGED AN EXISTING HOSPITALIZATION. THE SUBJECT IS A 83-YEAR-OLD MALE PATIENT. HE PRESENTED A RECTAL NEOPLASIA, SO IT WAS DECIDED TO UNDERGO A ROBOTIC SURGERY, ACCOMPANIED BY AN ABDOMINOPERINEAL AMPUTATION OF RECTUM AND INTERVENTION OF MILES ON (B)(6) 2023. THERE IS AN INCIDENTAL OPENING OF THE URETHRA DURING THE PROCEDURE DUE TO EXTREME PROXIMITY TO THE TUMOR. IT IS RESOLVED WITH A SUTURE DURING SURGERY. AFTER THE INTERVENTION, IT IS OBSERVED THAT THE SUBJECT HAS ABUNDANT DISCHARGE OF DIRTY FLUID FROM THE PERINEAL WOUND, CLINICALLY THE SUBJECT IS FINE. AN ATTEMPT WAS MADE TO PLACE A UROSTOMY BAG IN THE WOUND IN ORDER TO MEASURE THE VOLUME OF DISCHARGE, BUT WITHOUT SUCCESS. DUE TO THE ABUNDANT DISCHARGE OF DIRTY FLUID FROM THE PERINEAL WOUND, IT WAS DECIDED TO PLACE TWO PERCUTANEOUS NEPHROSTOMIES (BILATERAL NEPHROSTOMY). THIS PROCEDURE WILL BE PERFORMED DURING THE NEXT WEEK. THE EVENT IS CONSIDERED "ONGOING".

  Patient problems: Fistula

  MAUDE report 18141008 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE BECAME AWARE OF THIS EVENT YESTERDAY EVENING (26OCT2023). THE REPORTED SAE HAS BEEN DESCRIBED AS POSTSURGICAL HEMORRHAGE THROUGH PELVIC DRAINAGE. DECREASE OF HEMOGLOBIN TO 7.4 G/DL. TWO BLOOD TRANSFUSIONS OF RED BLOOD CELLS AND ADMINISTRATION OF TRANEXAMIC ACID PROLONGED AN EXISTING HOSPITALIZATION. THE SUBJECT IS A 75-YEAR-OLD MALE PATIENT. HE PRESENTED A MALIGNANT RECTAL NEOPLASIA, SO IT WAS DECIDED TO UNDERGO A ROBOTIC ULTRA-LOW ANTERIOR RECTUM RESECTION, A TOTAL MESORECTAL EXCISION, A MANUAL COLOANAL ANASTOMOSIS AND A PROTECTIVE ILEOSTOMY. SUBJECT UNDERWENT THIS SURGERY ON (B)(6) 2023. THIS EVENT INITIATED ON THE SAME AFTERNOON AS SURGERY (ON (B)(6) 2023) WHEN BLOOD WAS COMING OUT OF THE PELVIC DRAINAGE. BLEEDING WAS CONSTANT BUT THE PATIENT REMAINED HAEMODYNAMICALLY, SO THE ONLY TREATMENT CHOSEN IS THE ADMINISTRATION OF TRANEXAMIC ACID. OVER THE COURSE OF THE HOURS, VARIOUS BLOOD TESTS WERE CARRIED OUT, AND UPON OBSERVING THAT THE HAEMOGLOBIN LEVEL DROPPED TO 7.4 G/DL, IT WAS DECIDED TO PERFORM 2 BLOOD TRANSFUSIONS. AS THE DAYS GO BY, THE BLEEDING BECOMES LESS AND LESS (TRANEXAMIC ACID IS STILL ADMINISTERED), THE HAEMO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18022427 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT TODAY (18OCT2023), REPORTING THIS INFORMATION TO US THIS MORNING. THE REPORTED SAE HAS BEEN DESCRIBED AS LARGE POSTSURGICAL PNEUMOPERITONEUM, SUBCUTANEOUS EMPHYSEMA AND BILATERAL PLEURAL EFFUSION OBSERVED IN IMAGING TEST SUSPICIOUS OF GASTROINTESTINAL PERFORATION WHICH PROLONGED AN EXISTING HOSPITALIZATION. THE SUBJECT IS A 85-YEAR-OLD MALE PATIENT. HE PRESENTED A SIGMOID NEOPLASIA, SO IT WAS DECIDED TO UNDERGO A ROBOTIC SIGMOIDECTOMY ON (B)(6) 2023. DURING HOSPITALIZATION, ON (B)(6) 2023, THE SUBJECT WAS EVALUATED AFTER BEING NOTIFIED BY THE RADIOLOGY TEAM DUE TO THE PRESENCE OF PNEUMOPERITONEUM IN CT PERFORMED AT THE REQUEST OF THE VASCULAR SURGERY SERVICE DUE TO THE SUSPICION OF ISCHEMIA OF THE LMII. THE TC IMAGE SHOWED A LARGE POSTSURGICAL PNEUMOPERITONEUM, SUBCUTANEOUS EMPHYSEMA, AND BILATERAL PLEURAL EFFUSION SUSPICIOUS OF GASTROINTESTINAL PERFORATION. NO SIGNS OF ANASTOMOTIC DEHISCENCE. IT WAS DECIDED TO TREAT THE SUBJECT WITH PARENTERAL NUTRITION, OMEPRAZOLE, AND ANTIBIOTICS. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023, BUT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2023 DUE TO

  Patient problems: Pneumoperitoneum; Vomiting

  MAUDE report 17957241 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT TODAY ((B)(6) 2023), REPORTING THIS INFORMATION TO US THIS MORNING. THE REPORTED SAE HAS BEEN DESCRIBED AS POSTOPERATIVE PARALYTIC ILEUS WITH RECURRENT EPISODES OF VOMITS AFTER INTAKE. TREATMENT WITH METOCLOPRAMIDE, ONDANSETRON, PARENTERAL NUTRITION AND NASOGASTRIC TUBE WHICH PROLONGED AN EXISTING HOSPITALIZATION. THE SUBJECT IS A 80-YEAR-OLD FEMALE PATIENT. SHE PRESENTED A MALIGNANT NEOPLASIA OF THE RECTUM, SO IT WAS DECIDED TO UNDERGO AN ABDOMINOPERINEAL AMPUTATION AND A COLOSTOMY ON (B)(6) 2023. DURING HOSPITALIZATION, ON (B)(6) 2023. SHE PRESENTS GENERAL MALAISE, HEADACHE AND AN EPISODE OF RECURRENT VOMITING. THE SUBJECT ALSO SHOWED PAIN ON DEEP PALPATION OF THE HYPOGASTRIUM (ABDOMEN), WITH NO SIGNS OF PERITONEAL IRRITATION AND IT IS NOTED THAT THE ILEOSTOMY IS NON-FUNCTIONING . SHE IS TREATED WITH ANTIEMETICS, ABSOLUTE DIET AND FLUIDS. THE NEXT DAY, DUE TO THE LACK OF IMPROVEMENT, IT WAS DECIDED TO PLACE A NASOGASTRIC TUBE AND TO FEED PARENTERALLY. THIS EVENT WAS RESOLVED ON (B)(6) 2023.

  Patient problems: Abdominal Pain; Vomiting

  MAUDE report 17951533 ↗
• MalfunctionOct 16, 2023Ejection Problem; Ejection Problem

  WHEN THE DR USED THE CLIP APPLIER, THE CLIP APPLIER MISFIRED AND THE CLIP FELL OUT WITHOUT CLIPPING THE SYSTIC DUCT AT ALL. SO HE REMOVED IT AND WENT ON WITH THE REST OF THE CLIPS IN THE APPLIER. I TESTED THE CLIP APPLIER AGAIN THE NEXT DAY AND IT DID THE SAME. I TESTED ANOTHER CLIP APPLIER AND IT WORKED PERFECTLY. ACCORDING TO DR THIS HAPPENED ON TWO OCCASIONS. THE PATIENT WAS NOT HARMED IN ANY WAY AND DR COULD COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938976 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT YESTERDAY ((B)(6) 2023), REPORTING THIS INFORMATION TO US DURING TODAY. THE REPORTED SAE WAS DESCRIBED AS POST-SURGICAL PARALYTIC ILEUS, TREATMENT WITH NASOGASTRIC TUBE AND PARENTERAL NUTRITION WHICH LED TO A PROLONGED HOSPITALIZATION. THE SUBJECT IS A 55-YEAR-OLD MALE PATIENT, WHO SUFFERED FROM A LOCALLY ADVANCED NEOPLASM OF THE CECUM, FOR WHICH HE UNDERWENT A LAPAROSCOPIC RIGHT HEMICOLECTOMY AND LYMPHADENECTOMY ON (B)(6) 2023. ON (B)(6) 2023, THREE DAYS AFTER THE SURGERY THE PATIENT BEGAN TO HAVE ABDOMINAL PAIN AND WAS UNABLE TO DEFECATE. AN ABDOMINAL CT SCAN WAS PERFORMED WHICH SHOWED A PICTURE OF PARALYTIC ILEUS. IT WAS DECIDED TO PLACE A NASOGASTRIC TUBE AND PARENTERAL NUTRITION. THE EVENT IS STILL ONGOING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17747284 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED SAE WAS DESCRIBED AS MITRAL INSUFFICIENCY DUE TO LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION LEADING TO ABNORMAL SYSTOLIC MOVEMENTS WHICH LED TO A PROLONGED HOSPITALIZATION. THE SUBJECT IS A 58-YEAR-OLD MALE PATIENT. HE PRESENTED WITH HEPATOCARCINOMA AND CHRON'S DISEASE AND UNDERWENT LAPAROSCOPIC ILEOCOLIC RESECTION ON (B)(6) 2023. DURING THE SURGERY, TWO CLIPS WERE IMPLANTED IN A BLOOD VESSEL. ON (B)(6) 2023 THE SUBJECT EXPERIENCED LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION, WHICH LEAD TO SYSTOLIC ANTERIOR MOTION IN CONTEXT OF POSTOPERATIVE HYPOVOLEMIC SHOCK, HYPOTENSION (TREATED WITH NORADRENALINE) AND SEVERE ANEMIA. DURING THE POSTOPERATIVE PERIOD, THE SUBJECT HAD SEVERE MITRAL REGURGITATION WITH TENDINOUS CORD RUPTURE AND MITRAL VALVE PROLAPSE. PERIOPERATIVE ATRIAL FIBRILLATION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17315404 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT TODAY (19JUN2023), REPORTING THIS INFORMATION TO US EARLY THIS MORNING. THE REPORTED SAE WAS DESCRIBED AS POSTOPERATIVE PELVIC COLLECTION ADJACENT TO RECTUM, ANURIA AND PELVIC HEMATOMA WHICH LED TO A PROLONGED HOSPITALIZATION. THE SUBJECT IS A 71-YEAR-OLD MALE PATIENT. HE PRESENTED WITH NEOPLASIA OF THE LOWER RECTUM, SO IT WAS DECIDED TO UNDERGO AN ULTRA-LOW ANTERIOR RESECTION OF THE RECTUM AND A TERMINAL COLOSTOMY ON (B)(6) 2023. DURING THE INTERVENTION, THERE WAS A COMPLICATION DUE TO VENTILATION AND THE SURGERY WAS CONVERTED INTO AN OPEN PROCEDURE. ON (B)(6) 2023 THE SUBJECT WENT TO THE EMERGENCY DEPARTMENT FOR DIFFICULTY IN URINATING AND DISCOMFORT IN THE HYPOGASTRIUM. HE ALSO PRESENTED WITH FEVER. AN ABDOMINOPELVIC CT SCAN WITH IV CONTRAST SHOWED A POORLY DELIMITED LIQUID COLLECTION ADJACENT TO THE RECTAL STUMP AND POSTOPERATIVE CHANGES OF VASCULAR DISSECTION OF THE IMA. TREATMENT WITH PIPERACILLIN/TAZOBACTAM AND URINARY CATHETER. RECTAL DRAINAGE OF PELVIC COLLECTION AND HEMATOMA. ADMISSION TO HOSPITALIZATION WITH A DIAGNOSIS OF POST-SURGICAL COLLECTION.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 17173142 ↗
• MalfunctionJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT TODAY (24MAY2023), REPORTING THIS INFORMATION TO US DURING THIS MORNING. THE REPORTED SAE HAS BEEN DESCRIBED AS STOMA DEHISCENCE WITH EDEMA AND ERYTHEMA WHICH LED TO IN-PATIENT HOSPITALIZATION. THE SUBJECT IS A 68-YEAR-OLD MALE PATIENT. THIS SUBJECT UNDERWENT A LAPAROSCOPIC SIGMOIDECTOMY ON 20APR2023 FOR SIGMOID NEOPLASIA. IT IS WORTHY TO HIGHLIGHT THAT THIS SUBJECT SUFFERS FROM OBESITY AND HE HAS ALREADY SUFFERED A COMPLICATION OF THE INTERVENTION (ANASTOMOTIC LEAKAGE IN POSTOPERATIVE DAY 5 AFTER COLORECTAL SURGERY RESULTING IN ABDOMINAL COLLECTION), FOR WHICH HE HAD TO UNDERGO URGENT REOPERATION (ILEOSTOMY CONSTRUCTION). DURING THE POSTOPERATIVE TIME THE SUBJECT PRESENTS A DEHISCENCE OF THE STOMA WITH SUBCUTANEOUS FISTULAS AND ERYTHEMA OF THE AREA, ACCOMPANIED WITH FEVER. IT WAS TREATED WITH ANTIBIOTHERAPY AND ARGINATE. THIS PROBLEM CAUSED A DELAY OF 13 DAYS IN HOSPITAL DISCHARGE. ON (B)(6) 2023 HE WAS DISCHARGED FROM THE HOSPITAL. HOWEVER, DUE TO POOR MANAGEMENT AND WORSENING OF THE WOUND AT HOME, HE HAD TO BE REHOSPITALIZED ON (B)(6) 2023. ACCORDING TO THE INVESTIGATOR´S CRITERIA, THE SAE HAS BEE

  Patient problems: Post Operative Wound Infection

  MAUDE report 17167324 ↗
• MalfunctionJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED SAE HAS BEEN DESCRIBED AS RECTORRAGHIA: RECTAL BLEEDING AFTER RECTOSCOPY WHICH LED TO IN-PATIENT HOSPITALIZATION. THE SUBJECT IS A 71-YEAR-OLD MALE PATIENT. THIS PATIENT UNDERWENT AN LAPAROSCOPIC ULTRA-LOW ANTERIOR RECTUM RESECTION DUE TO A NEOPLASM IN THE RECTUM THAT WAS FOUND DURING A CT SCAN (THIS SUBJECT SUFFERS FROM METASTATIC CASTRATION-RESISTANT ADENOCARCINOMA OF THE PROSTATE. HE HAS BEEN UNDERGOING TREATMENT FOR YEARS). THIS RECTAL TUMOR WAS CONFIRMED AFTER A COLONOSCOPY PERFORMED ON (B)(6) 2023. THUS, IT WAS DECIDED TO PERFORM A PROTECTIVE ILEOSTOMY. THE SUBJECT WAS OPERATED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT ATTENDED A CHECK-UP WITH THE SURGEON AND UNDERWENT A RECTOSCOPY WITH AN OPAQUE ENEMA TO ASSESS THE SURGICAL CLOSURE OF THE STOMA. DURING THE RECTOSCOPY, BLEEDING OCCURRED WITHOUT MAJOR INCIDENTS, BUT CONTINUED FOR SEVERAL DAYS UNTIL (B)(6) 2023 WHEN HE WENT TO THE EMERGENCY DEPARTMENT AND WAS HOSPITALIZED FOR OBSERVATION AND COLONOSCOPY.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 17166889 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT BY THE END OF LAST WEEK (10MAR2023), REPORTING THIS INFORMATION TO US EARLY THIS MORNING. THE REPORTED SAE HAS BEEN DESCRIBED AS SUBCUTANEOUS EMPHYSEMA, WHICH LED TO A MEDICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 16544924 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURES PERFORMED ON THIS SUBJECT WERE A ROBOTIC PROCTECTOMY, ILEOANAL RESERVOIR AND A PROTECTIVE ILEOSTOMY. AS MENTIONED IN MY PREVIOUS COMMUNICATION, THE SUBJECT WAS PREVIOUSLY DIAGNOSED WITH ULCERATIVE COLITIS. THE TECHNIQUES COMPLETED DURING THE SURGERY ARE INDICATED BELOW: TROCAR INTRODUCTION. RELEASE OF MUCOSAL FISTULA. POSTERIOR AND LATERAL MESORECTAL DISSECTION WITH NERVE PRESERVATION UP TO THE PELVIC FLOOR. ANTERIOR DISSECTION OF THE RECTUM SEPARATING THE RECTOVAGINAL SEPTUM UP TO THE PELVIC FLOOR. RECTAL SECTION WITH TWO 60MM GREEN ROBOTIC ENDO STAPLER LOADS. RELEASE OF SMALL BOWEL MESENTERY ROOT TO DUODENUM. SECTION OF TERMINAL ILEUM WITH ROBOTIC ENDOGRAPATOR. EXTRACTION OF THE PIECE BY PFANNENSTIEL INCISION. EXTRACORPOREAL CONFECTION OF ILEOANAL RESERVOIR OF ABOUT 13-14 CM (3 LOADS 60 MM BEIGE SIGNIA). REINFORCEMENT OF THE ANTERIOR FACE WITH LOOSE VYCRIL STITCHES. MECHANICAL CIRCULAR RECTAL RESERVOIR ANASTOMOSIS 29 MM 4.8MM STAPLE HEIGHT. ANASTOMOSIS ABOUT 4-5 CM FROM ANAL MARGIN. LOOP ILEOSTOMY. CLOSURE OF INCISIONS. 20 DAYS AFTER THE SURGERY, THE SUBJECT GOES TO THE HOSPITAL REFERRING ACUTE PAIN IN THE ABDOMEN, WITH DAILY NAUSEA AND VOMITING (USUALLY AT NIGHT).

  Patient problems: Dehydration

  MAUDE report 16523406 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEMOPERITONEUM DERIVED FROM LAPAROSCOPIC GASTRECTOMY (SURGICAL ONCOLOGY) IN WHICH 5 CLIPS WERE IMPLANTED IN BLOOD VESSEL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16316042 ↗
• InjuryMay 28, 2019Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  A CLIP APPLIER WAS USED DURING A SURGICAL PROCEDURE. A SECOND OPERATION WAS REQUIRED 5 DAYS LATER AND A WOUND WAS OBSERVED ON THE CYSTIC DUCT. THERE WAS A NECROTIC WOUND LOCATED NEXT TO A NORMALLY PLACED CLIP.

  Patient problems: Tissue Damage

  MAUDE report 8646947 ↗
• MalfunctionMay 28, 2019Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  THE CLIP DID NOT LOAD PROPERLY ON FIRST USE OF THE CLIP APPLIER. THE JAWS CLOSED WITHOUT A CLIP IN PLACE AND CUT OFF THE CYSTIC DUCT;. THE PROCEDURE TIME WAS NOT EXTENDED.

  Patient problems: Tissue Damage

  MAUDE report 8646944 ↗