MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NON OPTICAL FLEXIBLE AND SEMIRIGID BIOPSY FORCEPS; BIOPSY FORCEPS, 28 CM

Model Number	27071ZJ
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the forceps broke while performing a stone rem.After the breakage the forceps could no longer be closed and therefore could not be removed from the bladder.The cystoscopy had to be converted to a laparotomy to remove the broken forceps from the bladder.

• Brand Name: NON OPTICAL FLEXIBLE AND SEMIRIGID BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS, 28 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19962724
• Report Number: 2020550-2024-00287
• Device Sequence Number: 12522006
• Product Code: OCZ
• UDI-Device Identifier: 04048551079133
• UDI-Public: 04048551079133
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/12/2024
• Report Date (Section F): 08/06/2024

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: 27071ZJ
• Device Catalogue Number: 27071ZJ
• Device Lot Number: RM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown