MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE CRUSHING FORCEPS, SGL. ACTION JAWS

Model Number	27074B
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.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 a stone crushing forceps would not close after a stone was lodged inside the jaws.This meant that the instrument couldn't be removed from the sheath during a cystoscopy.The surgeon had to revert to an open procedure to free the stone from the instrument so that it could be safely passed back through the cystoscopy sheaths.

• Brand Name: STONE CRUSHING FORCEPS, SGL. ACTION JAWS
• Common Device Name: FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19139743
• Report Number: 2020550-2024-00114
• Device Sequence Number: 15564657
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: 4048551079386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/18/2024
• Report Date (Section F): 04/18/2024

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: 27074B
• Device Catalogue Number: 27074B
• Device Lot Number: VY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• 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: Other
• Patient Sex: Unknown