MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER; SCISSORS, GENERAL, SURGICAL

Model Number RA-1651-001

Device Problem Component Missing (2306)

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

Event Date 07/24/2019

Event Type  malfunction  

Event Description

Patient was in a trigger finger and carpal tunnel procedure.During the procedure, the tip of the metz scissors was found missing.Unknown if tip was missing before or after surgery had started.The doctor did an x-ray of the surgical area and no foreign object was found.The operating room manager was called and risk was informed.

• Brand Name: V. MUELLER
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8869035
• MDR Text Key: 153532532
• Report Number: 8869035
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2019

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: No Information
• Device Model Number: RA-1651-001
• Device Catalogue Number: RA-1651-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA