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

Model Number	27072A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, and we have been unable to obtain any further details about the event to determine a possible cause of the laceration.The picture of the instrument provided by the customer shows the jaws are intact, and the rivet/ hinge pin (approx.1mm in size) is missing.If the pin (rivet) came off of the forceps during the procedure, this would not be likely to cause injury to the patient and the pin would most likely be passed when urinating.Per the lot code provided, the instrument had been in use for over 8 years.The most likely cause of the damage is wear of use.
Event or Problem Description
Allegedly, a rivet holding the biopsy cup jaw fell out during a urological procedure in which the patient sustained a minor injury (laceration), requiring a catheter until the laceration could heal.

• Brand Name: OPTICAL BIOPSY FORCEPS
• Common Device Name: OPTICAL BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 7575514
• Report Number: 9610617-2018-00040
• Device Sequence Number: 13971538
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 4048551079157
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: Physician
• Device Model Number: 27072A
• Device Catalogue Number: 27072A
• Device Lot Number: NZ
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/06/2018
• 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 Age: 81 YR