MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL GRASPING FORCEPS

Model Number	27072F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke inside the patient during a cystoscopy.An x-ray was taken, and it was confirmed that all pieces could be removed.
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).

• Brand Name: OPTICAL GRASPING FORCEPS
• Common Device Name: OPTICAL GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21204511
• Report Number: 2020550-2025-00038
• Device Sequence Number: 3810230
• Product Code: OCZ
• UDI-Device Identifier: 04048551079263
• UDI-Public: 04048551079263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/22/2025
• Report Date (Section F): 01/21/2025

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: 27072F
• Device Catalogue Number: 27072F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• 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
• Patient Sex: Unknown