MAUDE Adverse Event Report: CAREFUSION INC. SNOWDEN PENCER DIAMOND-LINE DISSECTOR BIOPSY FORCEP

Model Number	89-4000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch # mw5153422 that, ".I am writing to provide clarification of an incident that occurred on (b)(6) 2024, which involved a malfunction from a hand instrument that burned the surface of a patient's skin during a procedure.".
Additional Manufacturer Narrative
The medwatch report did not provide an initial reporter contact, a user facility name, user facility contact name or address.Steris is unable to contact the user facility to obtain additional information regarding the reported event.The snowden pencer diamond-line dissector biopsy forcep is a hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice for histopathological examination; it is not intended for endoscopic or catheterized access.It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together.It is not designed for cutting bone (i.E., not a rongeur).This is a reusable device.Steris contacted karl-storz to inquire if they received additional information from the user facility regarding the reported event or medwatch report however, karl-storz has not responded.As steris is unable to obtain additional information from the user facility and the device subject of the reported event cannot be returned for evaluation, a root cause cannot be determined.A follow-up report will be submitted should additional information become available.No additional issues have been reported.

• Brand Name: SNOWDEN PENCER DIAMOND-LINE DISSECTOR BIOPSY FORCEP
• Common Device Name: BIOPSY FORCEP
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19280337
• Report Number: 1423507-2024-01014
• Device Sequence Number: 15042629
• Product Code: GEI
• UDI-Device Identifier: 10885403156212
• UDI-Public: 10885403156212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 89-4000
• Device Catalogue Number: 89-4000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown