MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HANDLE

Model Number	30623UH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that the tip broke off, during use.No negative impact in state of health reported.During laparoscopic surgery on a four-year-old child, the 2.5 mm spherical fixation pin of a laparoscopic instrument (cuschieri liver retractor, 5 mm, manufactured by karl storz) became detached without being noticed.The postoperative x-ray showed the structure in the upper abdomen.The fixing pin was retrieved in a second operation on (b)(6) 2025 but was lost during retrieval.".
Additional Manufacturer Narrative
Update in section d1, d2, d4 and d10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The complained products (30623ui, 30623ua, 30623uh) were received on 2025-05-06 at the manufacturing site and were therefore available for investigation.The investigation has been completed on 2025-08-14.During the inspection, the following was found: 30623ui the complained failure description can be confirmed.The ball bearing at the end of the insert, which is used to lock the movable tip, is broken off.This means that locking is no longer possible.The facture surface does not reveal any material defect.30623ua the investigation did not reveal any faults or abnormalities on the outer shaft.The outer shaft is not related to the reported failure.30623uh the investigation revealed signs of wear consistent with its age.No further damage or defects can be detected.The wear patterns mentioned are not related to the reported failure.Based on the available information and the results of the examination, there is no indication for a material-, manufacturing- or design-related failure.The broken off tip is most likely due to an overload situation, which could be related to the age (manufacturing date 2011) of the instrument as it has likely been used and reprocessed a significant number of times.The corresponding ifu states that overloading the isnturment by exerting too much force may cause the medical device to break, bend and malfunction.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HANDLE
• Common Device Name: HANDLE
• 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: 21975907
• Report Number: 9610617-2025-00733
• Device Sequence Number: 12581085
• Product Code: GCJ
• UDI-Device Identifier: 04048551123683
• UDI-Public: 04048551123683
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 08/20/2025

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: 30623UH
• Device Catalogue Number: 30623UH
• Device Lot Number: OW
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 08/14/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/02/2025; 08/20/2025
• 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: 30623UA - LOT PL0130623UI - LOT: ZY01
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown