Single Use Electrosurgical Knife KD-640LRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170208423), received between Dec 7, 2018 and May 13, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 18, 2026.

Recalls naming this device

1. Mar 1, 2024Class IIOpen, Classified

   Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury

   Z-1547-2024 · Root cause: Use error · Recall details · FDA record ↗

2. Feb 17, 2024Class IIOpen, Classified

   A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

   Z-1222-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Airway Obstruction; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness; Pain; Pleural Effusion; Pneumoperitoneum; Pneumothorax; Pulmonary Emphysema; Unspecified Infection

  MAUDE report 22013756 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "TRANSVERSE VERSUS LONGITUDINAL MUCOSAL INCISION DURING POEM FOR ESOPHAGEAL MOTILITY DISORDERS: A RANDOMIZED TRIAL". LONGITUDINAL INCISION IS THE COMMONLY USED INCISION FOR ENTRY INTO THE SUBMUCOSAL SPACE DURING PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ESOPHAGEAL MOTILITY DISORDERS. TRANSVERSE INCISION IS ANOTHER ALTERNATIVE FOR ENTRY AND RETROSPECTIVE DATA SUGGEST IT HAS LESS OPERATIVE TIME AND CHANCE OF GAS-RELATED EVENTS. THIS WAS A SINGLE-CENTER, RANDOMIZED TRIAL CONDUCTED AT A TERTIARY CARE HOSPITAL. PATIENTS UNDERGOING POEM FOR ESOPHAGEAL MOTILITY DISORDERS WERE RANDOMIZED INTO GROUP A (LONGITUDINAL INCISION) AND GROUP B (TRANSVERSE INCISION). THE PRIMARY OBJECTIVE WAS TO COMPARE THE TIME NEEDED FOR ENTRY INTO THE SUBMUCOSAL SPACE. THE SECONDARY OBJECTIVES WERE TO COMPARE THE TIME NEEDED TO CLOSE THE INCISION, NUMBER OF CLIPS REQUIRED TO CLOSE THE INCISION, AND DEVELOPMENT OF GAS-RELATED EVENTS. THE SAMPLE SIZE WAS CALCULATED AS FOR A NON-INFERIORITY DESIGN USING KELSEY METHOD. SIXTY PATIENTS WERE RANDOMIZED (30 IN EACH GROUP). ON COMPARING THE 2 TYPES OF INCISIONS, THERE WAS NO DIFFERENCE IN ENTRY TIME [3 (2, 5)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20502390 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SUBLINGUAL NITROGLYCERINE SPRAY FACILITATES EFFICIENT SUBMUCOSAL TUNNELING DURING PER ORAL ENDOSCOPIC MYOTOMY-A NONRANDOMIZED TRIAL." LITERATURE SUMMARY: THIS STUDY DESCRIBES A NEW METHOD OF USING SUBLINGUAL NITROGLYCERINE SPRAY DURING SUBMUCOSAL TUNNELING TO FACILITATE THE PROCEDURE. THIS STUDY INCLUDES A COHORT OF 50 PATIENTS WHO WERE DIAGNOSED WITH ACHALASIA CARDIA ON HIGH-RESOLUTION ESOPHAGEAL MANOMETRY. ALL THE PROCEDURES WERE TECHNICALLY FEASIBLE AND SUCCESSFUL WITHOUT ANY MAJOR COMPLICATIONS. ECKHARDT¿S SCORES OF ALL PATIENTS NORMALIZED AFTER THE PROCEDURE. THE MEAN SUBMUCOSAL TUNNELING TIME AND MEAN TIME ACROSS GEJ WERE 36.8±7.9, 14.2±2.9 IN INTERVENTION GROUP (SUBLINGUAL NITROGLYCERINE), AND 50.2±8.9 AND 23.0±3.6 MINUTES IN NONINTERVENTION GROUP, RESPECTIVELY. TIME FOR EACH PROCEDURE WAS SIGNIFICANTLY LESS (P < 0.05) IN PATIENTS WHO WERE GIVEN SUBLINGUAL NITROGLYCERINE. ADVERSE EVENTS: ALL THE PROCEDURES WERE TECHNICALLY SUCCESSFUL WITHOUT ANY LONG-TERM COMPLICATIONS. THERE WAS MINIMAL MUCOSAL INJURY (TYPE 1) IN THREE PATIENTS (INTERVENTION GROUP 1 AND NONINTERVENTION 2) THAT WERE LEFT ALONE WITHOUT ANY CONSEQUENCE. TWO PAT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pleural Effusion

  MAUDE report 20038925 ↗
• InjuryJul 25, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE OLYMPUS REPRESENTATIVE ON BEHALF OF THE CUSTOMER. THE PROCEDURE PERFORMED WAS A THERAPEUTIC PERORAL ENDOSCOPIC MYOMECTOMY (POEM). THE PROCEDURE WAS PROLONGED BY APPROXIMATELY THREE MINUTES AND COMPLETED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391463 ↗
• InjuryMay 25, 2023Break; Melted; Break; Melted

  IT WAS ADDITIONALLY REPORTED THAT ONE OF THE DEVICE FRAGMENTS WAS UNABLE TO BE RETRIEVED. IT WAS UNKNOWN WHICH SPECIFIC KNIFE THIS APPLIED TO, HOWEVER, DESPITE ADDITIONAL FOLLOW UP. THE PHYSICIAN CLARIFIED THAT THE FRAGMENT FELL INTO THE PATIENT AT THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN FELT THAT THE FRAGMENT COULD NOT HAVE FALLEN INTO THE SURGICAL WOUND, AS IT WAS NOT BIG ENOUGH. IT WAS STATED THAT IT WAS LIKELY THAT IT SLIPPED THROUGH THE ESOPHAGUS AND INTO THE STOMACH. THE PHYSICIAN PERFORMED A GASTROSCOPY TO LOOK FOR THE FRAGMENT, BUT WAS UNABLE TO DETECT IT DUE TO FLUID IN THE STOMACH. NO ADDITIONAL IMAGING OR INTERVENTION HAS OCCURRED SINCE, AND THE PHYSICIAN EXPECTED THAT THE FRAGMENT WAS EXCRETED NATURALLY. THE PHYSICIAN STATED THAT THE PATIENT WAS DOING VERY WELL AS OF THE ADDITIONAL INFORMATION REPORT DATE AND THE EVENT TURNED OUT WELL FOR THEM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002647 ↗
• InjuryMay 25, 2023Break; Melted; Break; Melted

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC SUBMUCOSA DISSECTION DURING PERORAL ENDOSCOPIC MYOTOMY, THE FRONT PART OF THE SINGLE USE ELECTROSURGICAL KNIFE KD-645 BROKE OFF (ALSO STATED THAT IT MELTED) INSIDE OF THE PATIENT. THERE WERE THREE INSTANCES OF THIS HAPPENING DURING THE PROCEDURE. THE THREE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A TRIANGULAR TIP KNIFE. DUE TO THE PRODUCT ISSUES, THERE WAS A DELAY OF AN UNKNOWN LENGTH OF TIME. THERE WAS NOT A DETERIORATION IN THE PATIENT¿S HEALTH DUE TO THIS DELAY, AND THE OUTCOME OF THE PATIENT WAS STATED TO BE ¿OK.¿ PATIENT IDENTIFIERS (B)(6) CAPTURE THE THREE REPORTED INSTANCES. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002588 ↗
• InjuryMay 25, 2023Break; Melted; Break; Melted

  IT WAS ADDITIONALLY REPORTED THAT ONE OF THE DEVICE FRAGMENTS WAS UNABLE TO BE RETRIEVED. IT WAS UNKNOWN WHICH SPECIFIC KNIFE THIS APPLIED TO, HOWEVER, DESPITE ADDITIONAL FOLLOW UP. THE PHYSICIAN CLARIFIED THAT THE FRAGMENT FELL INTO THE PATIENT AT THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN FELT THAT THE FRAGMENT COULD NOT HAVE FALLEN INTO THE SURGICAL WOUND, AS IT WAS NOT BIG ENOUGH. IT WAS STATED THAT IT WAS LIKELY THAT IT SLIPPED THROUGH THE ESOPHAGUS AND INTO THE STOMACH. THE PHYSICIAN PERFORMED A GASTROSCOPY TO LOOK FOR THE FRAGMENT, BUT WAS UNABLE TO DETECT IT DUE TO FLUID IN THE STOMACH. NO ADDITIONAL IMAGING OR INTERVENTION HAS OCCURRED SINCE, AND THE PHYSICIAN EXPECTED THAT THE FRAGMENT WAS EXCRETED NATURALLY. THE PHYSICIAN STATED THAT THE PATIENT WAS DOING VERY WELL AS OF THE ADDITIONAL INFORMATION REPORT DATE AND THE EVENT TURNED OUT WELL FOR THEM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002448 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿THE POEM BOTTOM UP TECHNIQUE FOR ACHALASIA,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE GASTROINTESTINAL VIDEOSCOPE USED IN THE PROCEDURES CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL KNIFE USED IN THE PROCEDURES. BACKGROUND POEM (PER ORAL ENDOSCOPIC MYOTOMY) IS RAPIDLY BECOMING A VALID OPTION FOR SURGICAL MYOTOMY IN ACHALASIA PATIENTS. SEVERAL TECHNIQUES TO PERFORM POEM ARE DESCRIBED, BUT ALL CONCENTRATE ON THE DIVISION OF THE CIRCULAR MUSCLE FIBERS IN A PROXIMAL-TO-DISTAL FASHION. OUR AIM IS TO PRESENT THE DISTAL-TO-PROXIMAL, OR THE BOTTOM-UP TECHNIQUE USING THE FLUSH/DUAL KNIFE, WHICH OVERCOMES THE DISADVANTAGES OF THE STANDARD TECHNIQUE. METHODS A RETROSPECTIVE STUDY ON A PROSPECTIVELY MAINTAINED DATABASE WAS PERFORMED ON ALL PATIENTS TREATED BY POEM IN OUR INSTITUTION. CLINICAL PRESENTATION, OPERATING TIME, ADVERSE EVENTS, AND OUTCOMES WERE STUDIED. RESULTS POEM WAS PERFORMED ON 105 ACHALASIA PATIENTS. THE FIRST 15 CASES WERE PERFORMED USING THE STANDARD TECHNIQUE AND WERE COMPARED TO THE NEXT 90 CASES PERFORMED USING

  Patient problems: Fever; Unspecified Gastrointestinal Problem

  MAUDE report 16070926 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF TWO METHODS FOR ENDOSCOPIC FULL-THICKNESS RESECTION OF GASTROINTESTINAL LESIONS USING OTSC¿, TWO PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR (B)(6) FEMALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR (B)(6) FEMALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR (B)(6) FEMALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR (B)(6) FEMALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR (B)(6) MALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR (B)(6) MALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR (B)(6) MALE, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR (B)(6) MALE. STUDY BACKGROUND/AIM: THE AIM OF THIS STUDY WAS TO COMPARE AND ANALYZE THE FEASIBILITY AND SAFETY OF TWO METHODS OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE MANAGEMENT OF CHALLENGING EPITHELIAL AND SUBEPITH

  Patient problems: Abdominal Pain

  MAUDE report 14398710 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿COMPARISON OF TWO METHODS FOR ENDOSCOPIC FULL-THICKNESS RESECTION OF GASTROINTESTINAL LESIONS USING OTSC¿, TWO PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR 81 Y.O. FEMALE CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR 81 Y.O. FEMALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q260J USED IN THE PROCEDURE FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS CF-260AI USED IN THE PROCEDURE FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-640L USED IN THE PROCEDURES FOR 62 Y.O. MALE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-610L USED IN THE PROCEDURES FOR 62 Y.O. MALE. STUDY BACKGROUND/AIM: THE AIM OF THIS STUDY WAS TO COMPARE AND ANALYZE THE FEASIBILITY AND SAFETY OF TWO METHODS OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE MANAGEMENT OF CHALLENGING EPITHELIAL AND S

  Patient problems: Perforation

  MAUDE report 14398708 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PARAPNEUMONIC EFFUSION AND TENSION PNEUMOTHORAX AFTER DIVERTICULAR PERORAL ENDOSCOPIC MYOTOMY IN A WOMAN WITH LARGE EPIPHRENIC DIVERTICULUM: A CASE REPORT AND LITERATURE REVIEW". THE LITERATURE REPORTED THE RESULT OF PATIENTS WITH LARGE EPIPHRENIC DIVERTICULUM WHO UNDERWENT DIVERTICULAR PERORAL ENDOSCOPIC MYOTOMY PROCEDURE (D-POEM) USING OLYMPUS TRIANGLE-TIP KNIFE (KD-640L) AND ANOTHER DEVICE. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AFTER THE PROCEDURE AS FOLLOWS; - SUBCUTANEOUS EMPHYSEMA THE LITERATURE DESCRIBES THE PATIENT'S SYMPTOMS AND TREATMENT AS FOLLOWS. "SUBCUTANEOUS EMPHYSEMA OCCURRED ON THE RIGHT SIDE OF THE NECK AND CHEST IMMEDIATELY AFTER D-POEM, WITHOUT ANY UNSTABLE VITAL SIGNS BEING SEEN (FIG. 3A). HOWEVER, EXERTIONAL DYSPNEA WITH LEFT PLEURITIC PAIN DEVELOPED ON POSTOPERATIVE DAY 3; A CHEST CT SHOWED MASSIVE PLEURAL EFFUSION AND PULMONARY ATELECTASIS OF THE LEFT SIDE (FIG. 3B), INDICATING UNCOMPLICATED PARAPNEUMONIC EFFUSION VIA THORACENTESIS. A CHEST TUBE WAS IMMEDIATELY INSERTED WITH MAINTENANCE USING NEGATIVE PRESSURE, BUT A FOLLOW-UP ESOPHAGOSCOPY UNCOVERED A SPONTANEOUS MUCOSAL DEFECT WIT

  Patient problems: Dyspnea; Pleural Effusion

  MAUDE report 12974128 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF THE FOLLOWING LITERATURE ARTICLE, ENDOSCOPIC MUCOSAL INCISION AND MUSCLE INTERRUPTION (MIMI) FOR THE TREATMENT OF ZENKER¿S DIVERTICULUM (ZD). ALL PATIENTS WITH ZD WHO WERE TREATED BY FLEXIBLE ENDOSCOPY AT OUR INSTITUTION BETWEEN JANUARY 2015 AND FEBRUARY 2020 WERE IDENTIFIED BY A RETROSPECTIVE CHART REVIEW. DYSPHAGIA SYMPTOMS WERE ASSESSED USING A VALIDATED SCORING SYSTEM. NINETEEN PATIENTS WITH ZD UNDERWENT MIMI (MEAN AGE 76.1 YEARS, 68.1% MALE) AND SEVEN PATIENTS UNDERWENT NON-TUNNELED FLEXIBLE ENDOSCOPIC APPROACH (MEAN AGE 64.4 YEARS, 85.7% MALE) DURING THE STUDY PERIOD. THE AUTHORS CONCLUDED MIMI IS A TECHNICALLY FEASIBLE AND EFFECTIVE TREATMENT FOR ZD. CARE SHOULD BE TAKEN IN PATIENTS WITH A CRICOPHARYNGEAL BAR AND SMALL ZD, AS THIS MAY INCREASE THE RISK OF PERFORATION. LARGER STUDIES WITH LONG-TERM FOLLOW-UP ARE NEEDED TO DETERMINE IF MIMI REDUCES THE RISK OF SYMPTOM RECURRENCE WHEN COMPARED TO NON-TUNNELED FLEXIBLE ENDOSCOPIC APPROACHES. ALL CASES WERE PERFORMED USING THE OLYMPUS GIF-HQ190 WITH A NON-OLYMPUS BEVELED SILICONE-BASED ENDOSCOPIC CAP. THE VERTICAL INCISIONS WERE MADE WITH THE TRIANGLE TIP OLYMPUS KD-640L ON CUTTING CURRENT (EFFECT 2-1-2) A

  Patient problems: Abscess; Perforation

  MAUDE report 12961864 ↗
• InjuryDec 8, 2021Insufficient Device Problem Information

  OLYMPUS WAS NOTIFIED OF THE FOLLOWING LITERATURE ARTICLE, ENDOSCOPIC MUCOSAL INCISION AND MUSCLE INTERRUPTION (MIMI) FOR THE TREATMENT OF ZENKER¿S DIVERTICULUM (ZD). ALL PATIENTS WITH ZD WHO WERE TREATED BY FLEXIBLE ENDOSCOPY AT OUR INSTITUTION BETWEEN JANUARY 2015 AND FEBRUARY 2020 WERE IDENTIFIED BY A RETROSPECTIVE CHART REVIEW. DYSPHAGIA SYMPTOMS WERE ASSESSED USING A VALIDATED SCORING SYSTEM. NINETEEN PATIENTS WITH ZD UNDERWENT MIMI (MEAN AGE 76.1 YEARS, 68.1% MALE) AND SEVEN PATIENTS UNDERWENT NON-TUNNELED FLEXIBLE ENDOSCOPIC APPROACH (MEAN AGE 64.4 YEARS, 85.7% MALE) DURING THE STUDY PERIOD. THE AUTHORS CONCLUDED MIMI IS A TECHNICALLY FEASIBLE AND EFFECTIVE TREATMENT FOR ZD. CARE SHOULD BE TAKEN IN PATIENTS WITH A CRICOPHARYNGEAL BAR AND SMALL ZD, AS THIS MAY INCREASE THE RISK OF PERFORATION. LARGER STUDIES WITH LONG-TERM FOLLOW-UP ARE NEEDED TO DETERMINE IF MIMI REDUCES THE RISK OF SYMPTOM RECURRENCE WHEN COMPARED TO NON-TUNNELED FLEXIBLE ENDOSCOPIC APPROACHES. ALL CASES WERE PERFORMED USING THE OLYMPUS (B)(4) WITH A NON-OLYMPUS BEVELED SILICONE-BASED ENDOSCOPIC CAP. THE VERTICAL INCISIONS WERE MADE WITH THE TRIANGLE TIP OLYMPUS KD-640L ON CUTTING CURRENT (EFFECT 2-1-2) AND

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

  MAUDE report 12961850 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "PERORAL ENDOSCOPIC MYOTOMY ACHIEVES SIMILAR CLINICAL RESPONSE BUT INCURS LESSER CHARGES COMPARED TO ROBOTIC HELLER MYOTOMY, " FIVE PATIENTS IN THE PERORAL ENDOSCOPIC MYOTOMY (POEM) GROUP EXPERIENCED AN ADVERSE EVENT. THIS WAS A RETROSPECTIVE SINGLE CENTER REVIEW OF 52 CONSECUTIVE POEM PROCEDURES BETWEEN 2012-2014, AND 52 CONSECUTIVE RHM PROCEDURES BETWEEN 2009-2014 WITH THE PRIMARY AIM OF COMPARING THE INPATIENT CHARGES INCURRED BY PATIENTS UNDERGOING POEM OR ROBOTIC HELLER MYOTOMY (RHM) FOR THE TREATMENT OF ACHALASIA. IN ALL POEM CASES, AN OLYMPUS KD-640L WAS USED. THERE IS NO REPORT OF DEVICE MALFUNCTION DURING ANY OF THESE PROCEDURES. FIVE PATIENTS IN THE PERORAL ENDOSCOPIC MYOTOMY (POEM) GROUP EXPERIENCING AN ADVERSE EVENT (PNEUMOTHORAX (1), MUCOSTOMIES (4). NO INFORMATION WAS PROVIDED REGARDING ANY TREATMENT REQUIRED FOR THESE REPORTED EVENTS. THIS REPORT IS BEING SUBMITTED TO REPORT THE POTENTIAL THAT AN OLYMPUS DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO A REPORTED ADVERSE EVENT.

  Patient problems: Pneumothorax

  MAUDE report 11587850 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "PERORAL ENDOSCOPIC MYOTOMY ACHIEVES SIMILAR CLINICAL RESPONSE BUT INCURS LESSER CHARGES COMPARED TO ROBOTIC HELLER MYOTOMY, " FIVE PATIENTS IN THE PERORAL ENDOSCOPIC MYOTOMY (POEM) GROUP EXPERIENCED AN ADVERSE EVENT. THIS WAS A RETROSPECTIVE SINGLE CENTER REVIEW OF 52 CONSECUTIVE POEM PROCEDURES BETWEEN 2012-2014, AND 52 CONSECUTIVE RHM PROCEDURES BETWEEN 2009-2014 WITH THE PRIMARY AIM OF COMPARING THE INPATIENT CHARGES INCURRED BY PATIENTS UNDERGOING POEM OR ROBOTIC HELLER MYOTOMY (RHM) FOR THE TREATMENT OF ACHALASIA. IN ALL POEM CASES, AN OLYMPUS KD-640L WAS USED. THERE IS NO REPORT OF DEVICE MALFUNCTION DURING ANY OF THESE PROCEDURES. FIVE PATIENTS IN THE PERORAL ENDOSCOPIC MYOTOMY (POEM) GROUP EXPERIENCING AN ADVERSE EVENT (PNEUMOTHORAX (1), MUCOSTOMIES (4). NO INFORMATION WAS PROVIDED REGARDING ANY TREATMENT REQUIRED FOR THESE REPORTED EVENTS. THIS REPORT IS BEING SUBMITTED TO REPORT THE POTENTIAL THAT AN OLYMPUS DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO A REPORTED ADVERSE EVENT.

  Patient problems: Pneumothorax; Unspecified Tissue Injury

  MAUDE report 11582704 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 28, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "FEASIBILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR UPPER GASTROINTESTINAL SUBMUCOSAL TUMORS TREATMENT AND VALUE OF ENDOSCOPIC ULTRASONOGRAPHY IN PRE-OPERATION ASSESS AND POSTOPERATION FOLLOW-UP: A PROSPECTIVE STUDY OF 224 CASES IN A SINGLE MEDICAL CENTER". THIS STUDY WAS CONDUCTED THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR THE UPPER GASTROINTESTINAL SUBMUCOSAL TUMORS ON 224 PATIENTS BETWEEN JULY 2011 AND MARCH 2015. THE SUBJECT DEVICE, ENDOSCOPE, TRANSPARENT CAP, FORCEPS, NEEDLE, AND ENDOCLIP WERE USED DURING THE PROCEDURE. IN THE LITERATURE, IT WAS REPORTED THAT COMPLICATIONS OF PERFORATION, ABDOMINAL DISTENSION, CHEST TIGHTNESS OR SUBCUTANEOUS EMPHYSEMA, SECONDARY PERITONITIS, MASSIVE BLEEDING HAVE OCCURRED. THIRTEEN OF FOURTEEN CASES OF THE PERFORATION WERE CONSERVATIVELY MANAGED BY MEDICAL THERAPY AFTER APPLYING ENDOSCOPIC CLIPS, WITH EMERGENT OPERATION NEEDED IN ONLY ONE CASE. FIVE PATIENTS HAD MASSIVE BLEEDING DURING THE PROCEDURE OR POSTOPERATION, AND THREE OF THEM NEEDED TO RECEIVE EMERGENT OPERATION. THERE ARE NO DESCRIPTIONS OF DEVICE RELEVANCE FOR ALL ADVERSE EVENTS IN THE LITERA

  Patient problems: Blood Loss; No Code Available

  MAUDE report 10739912 ↗
• MalfunctionJun 11, 2020Break; Break

  AS REPORTED FOR THIS EVENT, DURING PROCEDURE THE DEVICE TRIANGLE TIP KNIFE BROKE OFF IN THE PATIENT. THE BROKEN TIP PIECE WAS RETRIEVED FROM PATIENT WITH STANDARD FORCEPS. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144871 ↗
• MalfunctionApr 23, 2019Break; Break

  DURING A PER-ORAL ENDOSCOPIC MYOTOMY, THE SUBJECT DEVICE WAS USED. THE DISTAL KNIFE OF THE SUBJECT DEVICE FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A GRASPING DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE FALLING OF THE DISTAL KNIFE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8538841 ↗
• MalfunctionDec 7, 2018Break; Difficult to Insert; Material Too Rigid or Stiff; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT AT THE END OF A PER ORAL PYLOROMYOTOMY (POP) PROCEDURE, THE TIP OF THE KNIFE AND A PIECE OF THE STEM WAS OBSERVED MISSING FROM THE DEVICE. AN EGD-ESOPHAGOGASTRODUODENOSCOPY AND FLUOROSCOPY WERE PERFORMED TO DETERMINE THE LOCATION OF DISTAL END/KNIFE AND IT ADDED AN ADDITIONAL 20-30 MINUTES UNDER ANESTHESIA FOR THESE EXTRA PROCEDURES. THE DEVICE FRAGMENTS WERE RETRIEVED FROM THE PATIENT'S STOMACH USING BIOPSY FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED. NO DEVICES OR EQUIPMENT WERE REPLACED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED BY THE NURSE AND THE PHYSICIAN PRIOR TO INSERTION INTO OF DEVICE INTO AN OLYMPUS 190 SCOPE (MODEL NOT SPECIFIED); NO ANOMALIES WERE NOTED. PER THE PHYSICIAN, THE KNIFE WAS NOTED TO BE SLIGHTLY STIFF TO INSERT. HOWEVER, THERE WAS NO RESTRICTION OF THE SCOPE AND NO DIFFICULTY WITHDRAWING KNIFE FROM SCOPE. NO SPARKING WAS OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8143240 ↗