MAUDE Adverse Event Report: KARL STORZ SE & CO. KG N.A.; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	27074B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Stone crusher and biopsy forcep noted to be broken during cystolithotripsy and cystolitholapaxy procedures.

• Brand Name: N.A.
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): KARL STORZ SE & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 9436902
• Report Number: 9436902
• Device Sequence Number: 4130219
• Product Code: OCZ
• UDI-Device Identifier: 04048551079386
• UDI-Public: (01)04048551079386
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2019
• Report Date (Section F): 11/18/2019

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: 27074B
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59
• Date Report Sent to FDA: 11/18/2019