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

Model Number	26184HSS
Medical Device Problem Code	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 vetseal 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 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).

• 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
• MDR Report Key: 22198358
• Report Number: 2020550-2025-01015
• Device Sequence Number: 8738187
• Product Code: GEI
• UDI-Device Identifier: 04048551102985
• UDI-Public: 04048551102985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2025
• Report Date (Section F): 06/10/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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