MAUDE Adverse Event Report: INTEGRA YORK PA, INC. /JARRITT SURGICAL INSTRUMENTS CRILE ARTERY FORCEPS (6 1/4") CURVED; CRILE CLAMP

Model Number 105-141

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

Approximately 5mm portion of ¿crile artery forceps (6 ¼¿) curved¿ clamp tip (1 tip) identified to be missing at the conclusion of the procedure.

• Brand Name: CRILE ARTERY FORCEPS (6 1/4") CURVED
• Type of Device: CRILE CLAMP
• Manufacturer (Section D): INTEGRA YORK PA, INC. /JARRITT SURGICAL INSTRUMENTS; york PA 17402
• MDR Report Key: 8378427
• MDR Text Key: 137560420
• Report Number: MW5084508
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2019

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
• Device Operator: Health Professional
• Device Model Number: 105-141
• Device Catalogue Number: 105-141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR