Single Use Electrosurgical Knife KD-645 KD-645LRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170407857), received between Sep 30, 2021 and Dec 6, 2024 — classified as 21 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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-1548-2024 · 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-1223-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20868568 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NONINFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED

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

  MAUDE report 20791833 ↗
• MalfunctionNov 5, 2024Material Separation; Material Separation

  DURING THE DEVICE EVALUATION, THE ELECTROSURGICAL KNIFE EXHIBITED THE DISTAL PORTION OF THE CUTTING KNIFE BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612619 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE HAD A SMALL FLAME SHOOT OUT OF THE BLADE, THE TRIANGULAR CERAMIC TIP DISINTEGRATED, AND THE HANDPIECE LEAKED. THE KNIFE ALSO COULD NO LONGER EXTEND. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS DELAYED ABOUT 15 MINUTES AND THE PATIENT WAS SEDATED WITH PROPOFOL. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264636 ↗
• InjuryApr 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE TRIANGLE TIP OF THE ELECTROSURGICAL KNIFE BROKE OFF DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE DUE TO THE NON-OLYMPUS GENERATOR OUTPUT BEING SET TOO HIGH. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175592 ↗
• InjuryApr 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE TRIANGLE TIP OF THE ELECTROSURGICAL KNIFE BROKE OFF DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE DUE TO THE NON-OLYMPUS GENERATOR OUTPUT BEING SET TOO HIGH. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175570 ↗
• MalfunctionApr 23, 2024Break; Melted; Break; Melted

  IT WAS REPORTED THE ELECTROSURGICAL KNIFE TIP MELTED AND FELL OFF. THE ISSUE OCCURRED DURING A HANDS-ON TRAINING DEMONSTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169606 ↗
• InjuryFeb 1, 2024Thermal Decomposition of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Detachment of Device or Device Component

  AS REPORTED, THE ELECTROSURGICAL KNIFE WAS BURNT AND FELL INTO THE PATIENT. THE ISSUE OCCURRED IN THE PATIENT'S ESOPHAGUS DURING PERORAL ENDOSCOPIC MYOTOMY PROCEDURE. THE PROCEDURE WAS "A BIT" PROLONGED BECAUSE THEY HAD TO USE FORCEPS TO REMOVE THE FALLEN PART. THE CUSTOMER MENTIONED THAT IT WAS SO SMALL (SHRUNK) THAT IT WAS NOT POSSIBLE TO PRESERVE IT; HOWEVER, THE DEFECT WAS CLEARLY VISIBLE ON THE KNIFE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DISSECTION KNIFE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627811 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED, "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION FOR CHALLENGING COLORECTAL LESIONS: A RANDOMIZED TRIAL" THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DIRECTLY COMPARE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR THE RESECTION OF CHALLENGING COLORECTAL LESIONS IN A RANDOMIZED TRIAL. 90 CONSECUTIVE PATIENTS WERE INCLUDED IN THE STUDY, EQUALLY REPRESENTING THE 3 CHALLENGING LESION TYPES. SUBGROUP ANALYSIS ACCORDING TO LESION TYPE: 1. LST-NG GROUP. A. EFTR GROUP. I. 2 PATIENTS PRESENTED WITH LATE BLEEDING AND WERE TREATED CONSERVATIVELY. B. ESD GROUP. I. A SINGLE RECURRENCE WAS FOUND AND MANAGED SUCCESSFULLY WITH EFTR. 2. NONLIFTING GROUP. A. EFTR GROUP. I. 2 PATIENTS PRESENTED WITH LOCAL RECURRENCE; BOTH WERE TREATED WITH STANDARD POLYPECTOMY. B. ESD GROUP. I. 2 PATIENTS HAD A PERFORATION DURING THE PROCEDURE AND WERE TREATED CONSERVATIVELY. 3. ADENOMA RELAPSE/RECURRENCE GROUP. A. EFTR GROUP. B. ESD GROUP. I. 1 PATIENT HAD A PERFORATION AND WAS TREATED CONSERVATIVELY. THIS MEDWATCH REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) : CF-H180DL; (B)(6) : GIF-H2

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18526619 ↗
• InjuryOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE GASTROENTEROLOGY PHYSICIAN REPORTED TO OLYMPUS THAT THE TRIANGLE PLATE OF THE SINGLE USE ELECTROSURGICAL KNIFE CAME OFF DURING THE DIAGNOSTIC PERORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE. THE KNIFE TIP WAS REMOVED VIA ASPIRATION. REPORTEDLY THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE AND PROCEDURE DID NOT TAKE LONGER THAN OTHERWISE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. REPORTEDLY, THE KNIFE TIP LOOKED BURNED EARLY IN THE PROCEDURE AND SETTINGS ON THE GENERATOR WERE CONFIRMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031618 ↗
• InjuryOct 17, 2023Thermal Decomposition of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE PERORAL ENDOSCOPIC MYOTOMY PROCEDURE, THE DISTAL PART OF THE DISSECTION KNIFE WAS BURNT AND FELL INTO THE PATIENT'S ESOPHAGUS. THE PROCEDURE WAS A BIT LONGER DUE TO THE RECOVERY OF THE FALLEN PART. THE BURNT BITS WERE SUCKED OUT AND THE PATIENT'S ESOPHAGUS WAS CLEAR. THE DEFECT WAS CLEARLY VISIBLE ON THE KNIFE, AS REPORTED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITIES OBSERVED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17950871 ↗
• InjuryOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS FURTHER RECEIVED INFORMATION THAT OLYMPUS DISTAL CAP WAS USED AS DISTAL ATTACHMENT WITH PERORAL ENDOSCOPIC MYOTOMY PROCEDURE. THE KNIFE WAS NOT ENERGIZED WHEN RETRACTING THE KNIFE INTO THE ENDOSCOPE. THE POWER SETTING WAS 5.6 PRECISE SECT/ ENDOCUT 2. THE ENERGIZATION TIME WAS 1-2 SECONDS DURING COAG. THE KNIFE WAS CLEANED ANYTIME IT IS REMOVED FROM THE SCOPE IN WATER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17921196 ↗
• InjuryOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS FURTHER RECEIVED INFORMATION THAT OLYMPUS DISTAL CAP WAS USED AS DISTAL ATTACHMENT WITH PERORAL ENDOSCOPIC MYOTOMY PROCEDURE. THE POWER SETTING WAS 5.6 PRECISE SECT/ ENDOCUT 2. THE ENERGIZATION TIME WAS 1-2 SECONDS DURING COAG. THE KNIFE WAS CLEANED ANYTIME IT IS REMOVED FROM THE SCOPE IN WATER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17921185 ↗
• InjurySep 26, 2023Thermal Decomposition of Device; Detachment of Device or Device Component; Thermal Decomposition of Device; Detachment of Device or Device Component

  THE TIP FALL OFF AT THE BEGINNING OF THE MYOTOMY, RIGHT AFTER THE INCISION. BUT IT CAN BE SAID THAT IT STARTED TO APPEAR ALREADY DURING THE INCISION. THE POWER SETTINGS IN (POEM) PERORAL ENDOSCOPIC MYOTOMY HAVE BEEN THE SAME IN THE PAST COUPLE OF YEARS. THE USER HAS USED VIO300D IN THE PAST. CO2 GAS WAS DELIVERED FOR THE PROCEDURE. DURING THE MYOTOMY SPRAYCOAG MODE WAS USED. THE USER USED TUNNELING FOR SPRAYCOAG MODE. NO VIDEO CAN BE PROVIDED FOR THE PROCEDURE IN QUESTION. THE TIP DROPOUT OCCURRED DURING SPRAYCOAG. THE ORDER OF THE POEM PROCEDURE FLOW WHEN THE TIP DROPOUT OCCURRED WAS: STANDARD POEM , INJECTION, INCISION, TUNNELING. NO MECHANICAL LOAD ON THE TIP DURING THAT INCISION. THE TIP DROPOUT WAS GRADUAL. THE TRIANGULAR TIP STARTED TO DEFORM DURING THE INCISION. USER USED THE SECOND MODE FOR THE INCISION. ENDO CUT MODE: EFFECT 2 WITH UPMAX:770, AND AGE CUR 1 WITH INTERVAL CUT 6. SPRAY COAGULATION MODE: EFFECT 2 WITH UPMAX 4300VP, AND MAX WATT 50.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818031 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿"TRANSANAL ENDOSCOPIC MICROSURGERY¿ WITH A FLEXIBLE COLONOSCOPE (F-TEM): A NEW ENDOSCOPIC TREATMENT FOR SUSPICIOUS DEEP SUBMUCOSAL INVASION T1 RECTAL CARCINOMA". LITERATURE SUMMARY: THE AIM OF THE STUDY WAS TO DESIGN A NEW FLEXIBLE COLONOSCOPE (F-TEM) TECHNIQUE, WHICH RETAINS THE ADVANTAGES OVER SURGICAL RESECTIONS WITH ELIMINATING THE DISADVANTAGES. A 60-YEAR-OLD PATIENT WAS DISCOVERED WITH A 15 MM DISTAL RECTUM ADENOCARCINOMA. ENDOSCOPIC EXAMINATION REVEALS A 15 MM, SUPERFICIAL, ELEVATED LESION, WITH A SLIGHTLY DEPRESSED CENTRAL PART. THE HISTOPATHOLOGICAL EXAMINATION REVEALED WELL DIFFERENTIATED (G1) T1 RECTAL ADENOCARCINOMA, WITH 800 M DEPTH OF SUBMUCOSAL INVASION WITHOUT LYMPHOVASCULAR INVASION/EMBOLI, LOW-GRADE BUDDING (BD1), AND NEGATIVE EXCISION MARGINS. THUS, THE STUDY CONCLUDES THAT F-TEM IS A FEASIBLE ALTERNATIVE TO SURGICAL RESECTION OR OTHER ENDOSCOPIC TREATMENTS SUCH AS ENDOSCOPIC SUBMUCOSAL OR INTERMUSCULAR DISSECTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS *HEMORRHAGE, STOPPED WITH A COAGRASPER HEMOSTATIC FORCEPS (1) THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED I

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17773941 ↗
• MalfunctionAug 31, 2023Break; Break

  THE CUSTOMER REPORTED THAT A TIP OF THE TRIANGLE (DISSECTION KNIFE) BROKE OFF, AND THERE WERE ONLY TWO TIPS LEFT. THE REPORTED ISSUE WAS OBSERVED DURING AN ORDINARY COLONIC DISSECTION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663328 ↗
• InjuryAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TIP OF THE TRIANGLE FELL OFF THE SHAFT OF THE SINGLE USE ELECTROSURGICAL KNIFE KD-645 INTO THE PATIENT AND WAS RETRIEVED WITH BIOPSY FORCEPS. THE PROCEDURE BEING DONE WAS AN E-POEM (PERORAL ENDOSCOPIC MYOTOMY) AND WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655696 ↗
• InjuryAug 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TIP OF THE TRIANGLE FELL OFF THE SHAFT OF THE SINGLE USE ELECTROSURGICAL KNIFE KD-645 INTO THE PATIENT AND WAS RETRIEVED WITH BIOPSY FORCEPS. THE PROCEDURE BEING DONE WAS AN E-POEM (PERORAL ENDOSCOPIC MYOTOMY) AND WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655622 ↗
• InjuryAug 22, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE ISSUE OCCURRED DURING A THERAPEUTIC PER-ORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE AND CAUSED AN APPROXIMATE 3 MINUTE DELAY. THE TIP CAME LOOSE INSIDE THE PATIENT, AND THE PART WAS RECOVERED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO USER OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600355 ↗
• InjuryAug 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE ISSUE OCCURRED DURING A THERAPEUTIC PER-ORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, WITH APPROXIMATELY THREE MINUTES DELAY. THE TIP CAME LOOSE INSIDE THE PATIENT, AND THE PART WAS RECOVERED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576333 ↗
• InjuryJul 10, 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 17289132 ↗
• InjuryApr 13, 2023Break; Break

  THE CUSTOMER REPORTED DURING A THERAPEUTIC PERORAL ENDOSCOPIC MYOTOMY FOR TYPE II ACHALASIA, THE SUBJECT DEVICE TIP "FELL OFF" DURING THE PROCEDURE. THERE WAS NO MELTING IDENTIFIED. THE CUSTOMER REPORTED THEY WERE UNABLE TO LOCATE THE TIP OF THE KNIFE. THE CUSTOMER DID NOT REPORT IF ADDITIONAL INTERVENTION WAS ATTEMPTED, INCLUDING DIAGNOSTIC TESTING TO LOCATE THE DEVICE. THERE WAS A FORTY (40) MINUTE PROCEDURAL DELAY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE AND WAS DETERMINED TO BE IN "EXCELLENT CONDITION." DUE TO THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER AND THE POTENTIAL FOR THE DEVICE TIP TO BE UNKNOWINGLY LEFT IN THE PATIENT, THIS WILL BE REPORTED AS A SERIOUS INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16736519 ↗
• InjuryApr 13, 2023Break; Break

  THE CUSTOMER REPORTED DURING A THERAPEUTIC PERORAL ENDOSCOPIC MYOTOMY FOR TYPE II ACHALASIA, THE SUBJECT DEVICE TIP "FELL OFF" DURING THE PROCEDURE. THERE WAS NO MELTING IDENTIFIED. THE CUSTOMER REPORTED THEY WERE UNABLE TO LOCATE THE TIP OF THE KNIFE. THE CUSTOMER DID NOT REPORT IF ADDITIONAL INTERVENTION WAS ATTEMPTED, INCLUDING DIAGNOSTIC TESTING TO LOCATE THE DEVICE. THERE WAS A FORTY (40) MINUTE PROCEDURAL DELAY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE AND WAS DETERMINED TO BE IN "EXCELLENT CONDITION." DUE TO THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER AND THE POTENTIAL FOR THE DEVICE TIP TO BE UNKNOWINGLY LEFT IN THE PATIENT, THIS WILL BE REPORTED AS A SERIOUS INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16735906 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED "PER-ORAL ENDOSCOPIC MYOTOMY WITH DIVISION OF SEPTUM (D-POEM) IN EPITHETIC ESOPHAGEAL DIVERTICULA: OUTCOMES AT A MEDIAN FOLLOW-UP OF TWO YEARS,¿ A PATIENT EXPERIENCED A MAJOR ADVERSE EVENT AFTER A PROCEDURE USING A GASTROVIDEOSCOPE AND A TRIANGULAR TIP KNIFE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE KNIFE USED IN THE PROCEDURE. ESOPHAGEAL EPIPHRENIC DIVERTICULA (EED) ARE RARE PULSION-TYPE OUTPOUCHINGS AT THE LOWER END OF ESOPHAGUS. TRADITIONALLY, SURGERY HAS BEEN PERFORMED IN EED. MORE RECENTLY, PER-ORAL ENDOSCOPIC MYOTOMY WITH SEPTOTOMY (D-POEM) HAS EMERGED AS AN OPTION IN THESE CASES. IN THIS STUDY, WE AIM TO DETERMINE THE EFFICACY AND SAFETY OF D-POEM IN CASES WITH EED. THE DATA OF CASES WHO UNDERWENT D-POEM IN CASES WITH EED FROM MARCH 2013 TO NOV 2020 WERE ANALYZED, RETROSPECTIVELY. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS. SECONDARY OUTCOMES INCLUDED TECHNICAL SUCCESS, PROCEDURE DURATION, REFLUX ESOPHAGITIS, AND ADVERSE EVENTS. 13 PATIENTS (MALES 9, 48.07 17.55 YEARS) WITH EED UNDERWENT D-POEM DURING THE STUDY PERIOD. MEDIAN SIZE OF THE EED

  Patient problems: Perforation of Esophagus

  MAUDE report 15682694 ↗
• InjuryDec 22, 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 "LONG-TERM OUTCOMES OF PER-ORAL ENDOSCOPIC MYOTOMY IN SPASTIC ESOPHAGEAL MOTILITY DISORDERS: A LARGE, SINGLE-CENTER STUDY". THE LITERATURE REPORTED THE RESULT OF 74 PATIENTS WITH SPASTIC ESOPHAGEAL MOTILITY DISORDERS (SEMD) WHO UNDERWENT PER-ORAL ENDOSCOPIC MYOTOMY (POEM) PROCEDURE USING OLYMPUS TRIANGULAR TIP KNIFE AND OTHER DEVICE. IN THE LITERATURE, THE FOLLOWING PERFORATION HAVE BEEN REPORTED TO HAVE OCCURRED. INSUFFLATION-RELATED EVENTS (15 CASES). MUCOSAL INJURIES (3 CASES). MUCOSAL BARRIER FAILURE (2 CASES). DELAYED BLEEDING (1 CASE). THE LITERATURE STATES AS FOLLOWS, "ADVERSE EVENTS WERE NOTICED IN 21 (28.4%) CASES. MILD ADVERSE EVENTS INCLUDED INSUFFLATION-RELATED EVENTS IN 15 (20.3%) AND MUCOSAL INJURIES IN 3 (4.1%) PATIENTS. MODERATE ADVERSE EVENTS INCLUDED MUCOSAL BARRIER FAILURE IN 2 (2.7%) AND DELAYED BLEEDING IN 1 (1.4%) PATIENT. ALL THE CASES WITH MILD ADVERSE EVENTS WERE MANAGED INTRAOPERATIVELY. THE CASES WITH MUCOSAL BARRIER FAILURE AT THE SITE OF MUCOSAL INCISION PRESENTED 10 AND 14 DAYS AFTER THE POEM PROCEDURE WITH SYMPTOM OF CHEST PAIN. ENDOSCOPY REVEALED SMALL DEFECT AT THE SITE OF MUCOSAL INC

  Patient problems: Chest Pain; Laceration(s) of Esophagus

  MAUDE report 13067514 ↗