MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	26055EB
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a "fluid leakage was observed during bipolar resection of uterine polyps.The leakage was so intense that the procedure had to be interrupted.Polyps were not removed.The leak occurred from the sheath and the working element.The procedure has not been completed".No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
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
Additional information is provided in section d10.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The products have been returned to karl storz tuttlingen on 2024-10-23.When examining the articles, the leakage could be reproduced.The articles were assembled and, in connection with air and water, the rising air bubbles could be seen at the working element.The location and the information from customers would match.On closer inspection, slight damage was noticed in the area of the teflon bushings on article 26055eb, which probably led to the leakage.After an evaluation of the article, such a leakage could not be found in other complaints.This is the first complaint in this direction, so a system error cannot be assumed.This defect can have occurred in different ways, for example, in the production site during manufacturing, but also at the end customer's site when cleaning with a brush or due to an incorrect loop.Since the error cannot be classified 100% and the evaluation data cannot provide any indication, the error cannot be determined.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: BIPOLAR
• 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: 20599987
• Report Number: 9610617-2024-00433
• Device Sequence Number: 18344080
• Product Code: HIH
• UDI-Device Identifier: 04048551258309
• UDI-Public: 04048551258309
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K221893
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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: 26055EB
• Device Catalogue Number: 26055EB
• Device Lot Number: NL04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/19/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/05/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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: MATERIAL NUMBER: 26055CB, BATCH: L04.; MATERIAL NUMBER: 26055EB, BATCH: NL04.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown