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

Model Number	27290M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that the forceps became defective during the very first pcnl surgery the forceps were used for.One of the grasper jaws had become loose from the joint after one stone has been removed during a pcnl procedure.The grasping forceps had been removed from the surgery at once.It was reported that the forceps shaft came off during a procedure.No negative impact in state of health reported.As the pin of the joint is missing this case deemed as reportable as precautionary action.
Additional Manufacturer Narrative
A connecting rivet has come loose in the joint.As the rivet was not sent in, this cannot be examined.It can be seen from the holes that they are out of round/deformed.It can be assumed that the rivet has been sheared off by excessive force and at the same time the material has been deformed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FORCEPS
• Common Device Name: FORCEPS
• 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: 18067971
• Report Number: 9610617-2023-00360
• Device Sequence Number: 18046151
• Product Code: FGA
• UDI-Device Identifier: 04048551082508
• UDI-Public: 4048551082508
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• PMA/510(K) Number: K940594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 27290M
• Device Catalogue Number: 27290M
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/30/2024
• 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
• Patient Sex: Unknown