MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. RANEY CLIPS; APPLIER, SURGICAL, CLIP

Model Number 070-001

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

During surgery, a package of raney clips was opened on the or table.When the contents were counted there were 11 in the package that was supposed to hold 10.Distributed by (b)(4) but manufactured by integra life sciences.Fda safety report id #(b)(4).

• Brand Name: RANEY CLIPS
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• MDR Report Key: 10396442
• MDR Text Key: 202928054
• Report Number: MW5096035
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 070-001
• Device Lot Number: 07445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 85 YR