MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS,OPITCAL BIOPSY, EXTRA LARGE; UROLOGY BIOPSY FORCEPS

Model Number	27072BSA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the instrument evaluation report, the linkage on jaws were broken off from the draw bar, a small piece was and it measures 0.5 x 1.1mm.The breakage most likely was from mechanical force and the small piece could be flushed out with an irrigant.
Event or Problem Description
Allegedly, during a bladder stone removal (lithotripsy retrieval of stone), while inside the patient, the jaws of the grasper became loose and the instrument was removed immediately.Dr.Replaced the grasper and completed the procedure.

• Brand Name: FORCEPS,OPITCAL BIOPSY, EXTRA LARGE
• Common Device Name: UROLOGY BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 8942020
• Report Number: 9610617-2019-00064
• Device Sequence Number: 16654518
• Product Code: OCZ
• UDI-Device Identifier: 04048551079225
• UDI-Public: 4048551079225
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: 27072BSA
• Device Catalogue Number: 27072BSA
• Device Lot Number: XR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/28/2019
• 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 Age: 50 YR
• Patient Weight: 68