MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OUTER TUBE, SIZE 3 MM

Model Number	26184HSS
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic spay in a canine patient the bipolar set was not working.The cauterization did not work.The product was stripped down and the insert taken out.A brand-new insert and new wire was used and still it did not work.In the end the procedure was reverted to placing a bigger port in and using the vet seal.This worked fine.The surgery was prolonged for more than 60 minutes.The patient had a slow recovery due to prolonged anesthetics.Cross reference mdr: 9610617-2025-01014, 9610617-2025-00999.
Additional Manufacturer Narrative
It was reported that during a laparoscopic spay procedure on a canine patient, the bipolar device - intended for human use - failed to function properly.Specifically, the cauterization feature was not operational.In response, the surgical team disassembled the device, removed the insert, and replaced it with a brand-new insert and wire.Despite these efforts, the device still did not work.Ultimately, the team decided to enlarge the surgical port and proceed using a vet seal device, which functioned as intended.However, due to the issues encountered, the procedure was prolonged by over 60 minutes.As a result, the canine patient experienced a slow recovery, attributed to the extended duration under anesthesia.The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned 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.Concomitant device 62176l has also been returned on june 4,2025.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the instruments were sent in for investigation and the investigation of the products was completed on october 16, 2025.The investigation of the instruments did not reveal the complete functional failure described by the customer.The investigation revealed that the insulation at the distal end of both forceps inserts were damaged.Although this defect is visible, it is not the cause of the problem described by the customer.The other instruments are in a used but functional condition.No defects were found on the instruments sent in that correspond to the fault description provided by the customer.This information indicates that the fault is not with the instruments, but most likely with the generator.The customer reports that after switching to the vet seal, everything worked perfectly.This leads to the conclusion that the generator originally used was not functioning correctly.Unfortunately, this generator was not sent in for examination, so a final assessment is not possible.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: OUTER TUBE, SIZE 3 MM
• Common Device Name: OUTER TUBE, SIZE 3 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• 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: 22198357
• Report Number: 9610617-2025-01015
• Device Sequence Number: 8738186
• Product Code: GEI
• UDI-Device Identifier: 04048551102985
• UDI-Public: 04048551102985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K962030
• 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
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26184HSS
• Device Catalogue Number: 26184HSS
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 10/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/17/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 62176L BIPOLAR HIGH FREQUENCY CORD, 300CM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown