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

Model Number 27072A

Device Problem Material Separation (1562)

Patient Problem Laceration(s) (1946)

Event Date 05/03/2018

Event Type  malfunction  

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 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
• Type of Device: OPTICAL BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7575514
• MDR Text Key: 110583122
• Report Number: 9610617-2018-00040
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 4048551079157
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K950434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 27072A
• Device Catalogue Number: 27072A
• Device Lot Number: NZ
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR