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

Model Number	R26159UHW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the case, the doctor grabbed a pollup, and they saw something fall out a piece of the grasper a very small spec of a piece.So they grabbed another grasper and manipulated like they normally do and they ended up having to grabbed another grasper to get the piece that broke off.The patient was not harmed.However, there was a 20-minute delay.They sent the patient for xray and did not find anything else.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device 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).

• Brand Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Common Device Name: BIOPSY AND GRASPING FORCEPS, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• MDR Report Key: 25361798
• Report Number: 2020550-2026-01257
• Device Sequence Number: 9985242
• Product Code: GCJ
• UDI-Device Identifier: 04048551094495
• UDI-Public: 04048551094495
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026
• Report Date (Section F): 06/02/2026

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: R26159UHW
• Device Catalogue Number: R26159UHW
• Device Lot Number: YK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• 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
• Patient Sex: Unknown