MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KUNTZ WORKING ELEMENT; Powered Laser Surgical Instrument

Model Number	27056LB
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an old, dry blood clot (from a previous patient) appeared to have entered the current patient's bladder through the handpiece when a sheath was inserted.Post operative bloods for blood borne virus were taken.Additional/ prolonged hospitalization was required.Although it can be assumed that the instrument is not the cause of the transferred residues, the case is classified as reportable as a precautionary measure.
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 d9, to reflect that the product was returned for evaluation.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
Device evaluation: the investigation of the product was completed on september 17,2024.A visual inspection was carried out.The device is heavily corroded.Based on the failure description and the visual inspection of the returned device the most likely cause is incorrect/inadequate reprocessing.If the shaft/ working channels are not cleaned with the appropriate bruches, residues may remain inside.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: KUNTZ WORKING ELEMENT
• Common Device Name: Powered Laser Surgical Instrument
• 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: 19795104
• Report Number: 9610617-2024-00224
• Device Sequence Number: 11799433
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2026

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: 27056LB
• Device Catalogue Number: 27056LB
• Device Lot Number: PM02
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 09/17/2024; 09/04/2026
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/23/2024; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown