MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE HANDLE,METAL; METAL HANDLE WITH SWING AWAY RATCHET

Model Number	33132
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufactures internal complaint number is (b)(4).Per facility the product cannot be located.Should relevant additional information/investigation results become available, a supplemental medwatch will be submitted unsolicited.
Event or Problem Description
It was reported that there was an issue with the product 33132 handle metal manhès style ratchet.According to the information received, during an xi robotic lap hysterectomy, one side of the jaw of a hunter grasper broke and the jaw/blade of the grasper fell deep in the abdomen.The blade was recovered laparoscopically.Patient harm is not known at date of this report.Additional information has been requested but not yet received as of the date of this report and additional patient information is not available.
Additional Manufacturer Narrative
Product investigation report.Final investigation without product.The product was not returned to karl storz tuttlingen.Therefore, the product inspection could not be carried out in our warehouse.Lot is unknown.Conclusion and root cause determination: user-related.Since the article was not sent in for investigation no precise investigation is possible.In addition, only one handle was reported, the customer's order states that a pliers insert is broken.The age of the handle is also unknown, and the medwatch report that was sent in also states that the article was repaired by a third party.A possible cause could be the application of excessive force.Ifu 97000025 v4.2 02/2020 notes a warning of exerting too much force may cause the medical device to break, bend and malfunction.Do not overload the instruments.The end of the products life is largely determined by wear, reprocessing methods, the chemicals used and any damage resulting from use.

• Brand Name: CLICKLINE HANDLE,METAL
• Common Device Name: METAL HANDLE WITH SWING AWAY RATCHET
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16146363
• Report Number: 9610617-2023-00010
• Device Sequence Number: 12176071
• Product Code: GCJ
• UDI-Device Identifier: 04048551125281
• UDI-Public: 4048551125281
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 33132
• Device Catalogue Number: 33132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female