MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY FORCEPS, SINGLE ACTION JAWS, 1MM X 60CM

Model Number	11161KA
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently with the manufacturer for investigation.
Event or Problem Description
As per a manufacturer incident report we received from the factory in germany: the biopsy forceps got stuck inside the patient as the jaws could not be closed so they could not be withdrawn from the endoscope.
Additional Manufacturer Narrative
Manufacturer's evaluation findings: the inner wire was broken off.The inner wire has the function to close the jaw by pulling down, if the wire is disconnected, the jaw could not be closed.There is evidence of inner wire stretched out before it broke.The most potential root cause is due to exerting too much pulling force leading the inner wire to break.After evaluation we found the device was mis-used and abused by user.Also, there is no information of harm to patient and user.

• Brand Name: BIOPSY FORCEPS, SINGLE ACTION JAWS, 1MM X 60CM
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 10713005
• Report Number: 9610617-2020-00113
• Device Sequence Number: 3246628
• Product Code: GWG
• UDI-Device Identifier: 04048551050460
• UDI-Public: 4048551050460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K002788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 11161KA
• Device Catalogue Number: 11161KA
• Device Lot Number: ZR01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention