MAUDE Adverse Event Report: V.MUELLER / CAREFUSION 2200, INC. V.MUELLER LEWIN CLAMP; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number NL6960

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Event Description

Dr was using clamp to remove the head of the femur due during the surgical case.The jaws broke and was retrieved using c-arm.Fda safety report id# (b)(4).

• Brand Name: V.MUELLER LEWIN CLAMP
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): V.MUELLER / CAREFUSION 2200, INC.
• MDR Report Key: 11404115
• MDR Text Key: 234649069
• Report Number: MW5099730
• Device Sequence Number: 1
• Product Code: GEN
• 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: 02/26/2021

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: NL6960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• 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 Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 94