n.a. 37370DLRecalls & reported problems
Karl Storz GmbH & Co. KG · Coagulating and Dissecting Electrode · Class 2
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04048551155653), received between Oct 18, 2019 and Jul 1, 2026 — classified as 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Material Separation5
- Material Fragmentation2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT THE HOOK BROKE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680143 ↗MalfunctionJul 1, 2025Break; Break
ACCORDING TO THE INFORMATION RECEIVED, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ELECTROCAUTERY HOOK BROKE WITHIN THE SURGICAL SITE. THE FRAGMENT WAS FULLY RETRIEVED WITHOUT ANY COMPLICATIONS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378804 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT "DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE COAGULATOR HOOK BROKE AND FELL INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS SPOTTED BY ENDOSCOPY AND REMOVED IN ITS ENTIRETY FROM THE ABDOMINAL CAVITY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21882659 ↗MalfunctionMar 21, 2025Break; Break
IT WAS REPORTED THAT PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY, USING A NON-DISPOSABLE LAPAROSCOPIC CAUTERY DEVICE "L" HOOK, TIP BROKE OFF OF HANDPIECE, WAS RETRIEVED BY MD WITH NO ISSUES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663089 ↗MalfunctionOct 25, 2023Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE 37370DL HAD BROKEN INSIDE THE PATIENT'S BODY. THE USER HAD BEEN ABLE TO RETRIEVE ALL PIECES THAT THEY COULD FIND, AND NO HARM OCCURRED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004650 ↗MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT HAD ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED ON THEM. A SMALL 1MM MISSING PLASTIC PIECE WAS FOUND AT THE TIP OF THE HOOK AT THE END OF THE PROCEDURE. A SIMILAR PIECE WAS FOUND IN THE SUCTION BOTTLE LATER. BUT WE CANNOT CONFIRM IT IS THE MISSING PART OF THE HOOK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060265 ↗MalfunctionNov 4, 2022Material Separation; Material Separation
THE EVENT OCCURRED IN CHINA: IT WAS REPORTED THAT THE HOOK WAS BROKEN DURING SURGERY. THE BROKEN PART FELL INTO THE PATIENT'S BODY BUT COULD SUCCESSFULLY BE RETRIEVED. NO HARM TO PATIENT, USER OR THIRD REPORTED. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15735415 ↗InjuryNov 4, 2022Material Separation; Material Separation
THE EVENT OCCURRED IN CHINA: IT WAS REPORTED THAT THE HOOK WAS BROKEN DURING SURGERY. THE BROKEN PART FELL INTO THE PATIENT'S BODY BUT COULD SUCCESSFULLY BE RETRIEVED. NO HARM TO PATIENT, USER OR THIRD REPORTED. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15735365 ↗MalfunctionNov 6, 2020Material Separation; Material Separation
ALLEGEDLY PER THE CUSTOMER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE ITEM BROKE AT TIP WHILE INSIDE THE PATIENT. THE PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO OTHER INTERVENTION AND NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10804377 ↗MalfunctionJul 24, 2020Material Fragmentation; Material Fragmentation
AS PER A MANUFACTURE INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4) WHICH WAS FILED WITH THE (B)(4): DURING THE OPERATION, THE HOOK DETACHED FROM THE HOOK ELECTRODE AND COULD NO LONGER BE FOUND IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10323250 ↗MalfunctionJan 27, 2020Material Fragmentation; Material Fragmentation
PER THE FACTORY IN (B)(4), ALLEGEDLY THERE WAS AN EVENT WHICH OCCURRED IN (B)(6) THAT THE HOOK BROKE OFF AND WAS INTRAOPERATIVE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9634181 ↗MalfunctionDec 6, 2019Material Separation; Material Separation
ALLEGEDLY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE L HOOK TIP OF THE ELECTRODE FELL INSIDE THE PATIENT; THE DOCTOR WAS ABLE TO RETRIEVE THE PIECE SUCCESSFULLY WITH NO HARM TO THE PATIENT AND THE PROCEDURE COMPLETED.
Patient problems: Foreign Body In Patient
MAUDE report 9432345 ↗MalfunctionOct 18, 2019Material Separation; Material Separation
ALLEGEDLY PER THE CUSTOMER, DURING A LAPAROSCOPIC SIGMOID RESECTION THE INSTRUMENT DISINTEGRATED, ITEM BROKE AT TIP WHILE INSIDE THE PATIENT. THE PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO OTHER INTERVENTION AND NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9210085 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.