Single Use Electrosurgical KnifeRecalls & reported problems across all models

We found 9 models of Single Use Electrosurgical Knife by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 509 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2018 and Aug 7, 2025 — classified as 4 deaths, 295 injuries, 210 malfunctions.

The most frequently reported specific device problem is “Break” (255 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Single Use Electrosurgical Knife recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 1, 2024Open, 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, 2024Open, 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 Single Use Electrosurgical Knife problems

Single Use Electrosurgical Knife models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Electrosurgical Knife KD-611L

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 death357 reports
• Single Use Electrosurgical Knife KD-640L

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 recalls19 reports
• Single Use Electrosurgical Knife KD-620LR

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 death48 reports
• Single Use Electrosurgical Knife KD-610L

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 deaths42 reports
• Single Use Electrosurgical Knife KD-630L

  Unit, electrosurgical, endoscopic (with or without accessories)
  17 reports
• Single Use Electrosurgical Knife KD-620QR

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  11 reports
• Single Use Electrosurgical Knife KD-620LR

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  10 reports
• Single Use Electrosurgical Knife KD-620QR

  Unit, electrosurgical, endoscopic (with or without accessories)
  4 reports
• Single Use Electrosurgical Knife KD-620UR

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report

Recent Single Use Electrosurgical Knife adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC SEPTOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. IT WAS OBSERVED THAT THE OPERATOR WAS USING THE DEVICE WITH A LOT OF ENERGY IN THE CUT MODE. THE OPERATOR LOOKED FOR THE TIP THAT FELL OFF INSIDE THE PATIENT BUT COULD NOT FIND IT. THE FALLEN TIP WAS NOT RETRIEVED. THE USERS REPORTEDLY WERE NOT WORRIED ABOUT IT TOO MUCH. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND COMPLETED SUCCESSFULLY WITH A DIFFERENT KNIFE. THE PATIENT WAS STABLE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22742969 ↗
• InjuryAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC SEPTOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. IT WAS OBSERVED THAT THE OPERATOR WAS USING THE DEVICE WITH A LOT OF ENERGY IN THE CUT MODE. THE OPERATOR LOOKED FOR THE TIP THAT FELL OFF INSIDE THE PATIENT BUT COULD NOT FIND IT. THE FALLEN TIP WAS NOT RETRIEVED. THE USERS REPORTEDLY WERE NOT WORRIED ABOUT IT TOO MUCH. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND COMPLETED SUCCESSFULLY WITH A DIFFERENT KNIFE. THE PATIENT WAS STABLE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22742955 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2 CM (2.6%) (P< 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

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

  MAUDE report 22133183 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Unspecified Infection

  MAUDE report 22127712 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY: BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2CM (2.6%) (P<0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P=0.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22127675 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Unspecified Infection

  MAUDE report 22127660 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P <0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22127654 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2CM (2.6%) (P< 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 22127547 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

  Patient problems: Bowel Perforation; Pleural Effusion; Unspecified Infection

  MAUDE report 22127507 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER = 2 CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER < 2 CM (2.6%) (P < 0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%)

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

  MAUDE report 22127400 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION FOR DUODENAL SUBEPITHELIAL LESIONS." LITERATURE SUMMARY BACKGROUND AND AIM: THIS WORK AIMS TO EVALUATE THE EFFICACY AND SAFETY OF FREE-HAND ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) FOR DUODENAL SUBEPITHELIAL LESIONS (SELS). METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 105 PATIENTS WITH DUODENAL SELS WHO UNDERWENT FREE-HAND EFTR. FREE-HAND EFTR MEANS NO OTHER DEVICES (OVER-THE-SCOPE CLIP OR FULL-THICKNESS RESECTION DEVICE) ARE REQUIRED. THE PREOPERATIVE BASELINE DATA, PROCEDURE-RELATED CHARACTERISTICS, AND POSTOPERATIVE OUTCOMES WERE ANALYZED. RESULTS: THE TECHNICAL SUCCESS RATE WAS 99.0%, AND THE EN BLOC RESECTION RATE WAS 94.2%. A TOTAL OF NINE (8.7%) PATIENTS EXPERIENCED MAJOR POSTOPERATIVE ADVERSE EVENTS (AES). THE INCIDENCE OF MAJOR AES WAS SIGNIFICANTLY HIGHER FOR LESIONS WITH A MAXIMUM DIAMETER =2CM (30.4%) THAN FOR LESIONS WITH A MAXIMUM DIAMETER <2CM (2.6%) (P<0.001). THERE WERE ALSO SIGNIFICANT DIFFERENCES IN THE INCIDENCE OF MAJOR AES FOR PERI-AMPULLARY LESIONS (37.5%), BULB LESIONS (4.8%), BULB-DESCENDING JUNCTION LESIONS (6.7%), AND DESCENDING PART LESIONS (12.5%) (P=0.0

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 22127252 ↗
• 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 ↗
• InjuryDec 11, 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 20909724 ↗
• InjuryDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE KNIFE FELL OFF AND INTO THE PATIENT¿S STOMACH DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE PROCEDURE WAS DELAYED FOR 15 MINUTES TO RETRIEVE THE DEVICE. ALTHOUGH REQUESTED, IT IS UNKNOWN HOW THE DEVICE WAS RETRIEVED, AND IF ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859655 ↗
• InjuryNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGERY, THE TIP OF THE KNIFE WIRE FELL OFF INTO THE PATIENT'S BODY AND WAS RETRIEVED. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745778 ↗

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