MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY FORCEP; BIOPSY FORCEP FLEXIBLE 1MM

Model Number	1116KA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was event with a 11161ka biopsy forceps flexible.The handle on the biopsy grasper failed and did not open or close.The procedure was ceased and rescheduled for another day.Per the or nurse no injury to the patient as it was never inserted into the patient.
Additional Manufacturer Narrative
Investigation on-going.Product currently has not been returned for evaluation it remains at the facility.Should the product be sent in later with additional information/investigation results a supplemental medwatch will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).As of today, three other similar case has been found.The manufacture continues to review and investigate.
Additional Manufacturer Narrative
Per manufacture evaluation findings; on the product, it could be determined that the tension wire is worn on the inside.The way the ends have opened up it can be assumed that it has torn under tension.There is also a clear kink at the transition to the flexible area.Impressions/deformation can be seen on the knurled screw, which indicates that this was opened using pliers or something else.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
Per evaluation findings; the shaft is bent at proximal end causing coil separation.Damage to the locking mechanism that correlate with the customer unscrewing it.A possible cause is user error which could have resulted from the use of pliers to unscrew it.The tension rod broken; causing the jaws to not operate.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: BIOPSY FORCEP
• Common Device Name: BIOPSY FORCEP FLEXIBLE 1MM
• 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: 17415116
• Report Number: 9610617-2023-00192
• Device Sequence Number: 18398406
• Product Code: GWG
• UDI-Device Identifier: 04048551050460
• UDI-Public: 4048551050460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002788
• 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,Followup
• Report Date (Section B): 12/14/2023

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: 1116KA
• Device Catalogue Number: 1116KA
• Device Lot Number: PO01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/11/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 12/14/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown