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

Model Number	27072A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned and therefore, could not be evaluated.
Event or Problem Description
Allegedly, per the customer during a bladder stone procedure the forceps cup bent and would not open.Per the customer "we broke cup to remove from sheath", nothing fell inside the patient and procedure was completed with no further intervention required or harm to the patient.
Additional Manufacturer Narrative
The evaluation of the returned instrument date code nr08(01/2018) distal end of shaft is crushed and tip and jaws are missing.

• Brand Name: OPTICAL BIOPSY FORCEPS
• Common Device Name: OPTICAL GRASPING FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 10487715
• Report Number: 9610617-2020-00098
• Device Sequence Number: 19471061
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 4048551079157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27072A
• Device Catalogue Number: 27072A
• Device Lot Number: NR
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: 76 YR
• Patient Weight: 84