MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING INSERT, 5X

Model Number	26167FGE
Medical Device Problem Codes	Break (1069); Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "2 x working insert forceps short circuited during use in patient.The first insert was used and short circuited, then the customer tried another insert and it happened again.This resulted in extra time being needed to check that the procedure worked without any incident or harm to the patient.The procedure could be completed with the 2 x compromised inserts.Working inserts was reported as burnt out." furthermore, it was stated that the reported issue added 15-20 minutes more to the procedure.No negative impact in state of health reported.Based on the information that the working insert forceps short circuited in the patient, this case is deemed reportable as a precautionary measure.
Additional Manufacturer Narrative
Additional information added in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It has been confirmed that the two working inserts involved in the reported short-circuit incident during the procedure are non-karl storz products.However, the event remains reportable, as it cannot be conclusively ruled out that karl storz devices may have contributed to or influenced the reported issue.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction added in section b5.Device evaluation: during investigation of the returned instruments, it was determined that the working inserts were manufactured by karl storz (article# 26167fge) and were manufactured approximately 10 years ago.Significant mechanical damage was found on the distal ends of the working inserts, which is considered to be the cause of the reported issue ("short circuited during use").The other returned items (26167fgr - handle, 26167fgf - outer tube, 26176lv- high frequency cord) showed only normal signs of wear, but no technical, mechanical, or thermal damage, and it is concluded that they are not causative for the reported issue.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Initially it was reported that the working inserts were non-karl storz products, but upon return and investigation of the concerned working inserts at the manufacturer's site, it was found that the working inserts are indeed karl storz products (article# 26167fge).

• Brand Name: WORKING INSERT, 5X
• Common Device Name: WORKING INSERT, 5X
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23438669
• Report Number: 9610617-2025-01964
• Device Sequence Number: 8672222
• Product Code: GCJ
• UDI-Device Identifier: 04048551095270
• UDI-Public: 04048551095270
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26167FGE
• Device Catalogue Number: 26167FGE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 02/10/2026; 02/26/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/10/2025; 02/10/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26176LV (BIPOLAR HIGH FREQUENCY CORD, 300 CM).; ARTICLE: 26167FGF (OUTER TUBE).; ARTICLE: 26167FGR (HANDLE), LOT: YX.
• Patient Sex: Unknown