MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY SPOON FORCEPS, 5 FR.

Model Number	26160BHW
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the screw near the spoon of the biopsy spoon forceps came off during the procedure.The surgeon was able to locate the screw inside the patient and took it out.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was returned to our us facility on 09/08/2025.It will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the rivet came loose because the weld on the jaw part was not deep enough.Additionally, the countersink on the jaw part was too small.The corresponding operating instructions refer to a visual and functional inspection of the device and that overloading should be avoided.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the rivet came loose because the weld on the jaw part was not deep enough.Additionally, the countersink on the jaw part was too small.The corresponding operating instructions refer to a visual and functional inspection of the device and that overloading should be avoided.This event is filed under internal complaint id (b)(4).

• Brand Name: BIOPSY SPOON FORCEPS, 5 FR.
• Common Device Name: BIOPSY SPOON FORCEPS, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22680977
• Report Number: 9610617-2025-01339
• Device Sequence Number: 9447888
• Product Code: GCJ
• UDI-Device Identifier: 04048551094518
• UDI-Public: 04048551094518
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934937
• 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,Followup
• Report Date (Section B): 02/12/2026

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: 26160BHW
• Device Catalogue Number: 26160BHW
• Device Lot Number: UM02
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 02/02/2026; 02/02/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/10/2025; 02/10/2026; 02/12/2026
• 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: Female