MAUDE Adverse Event Report: CODMAN / SYMMETRY SURGICAL GMBH CODMAN NEEDLE HOLDER; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 36-2017

Device Problem Break (1069)

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

Event Date 07/16/2019

Event Type  malfunction  

Event Description

Rubber coating on endoscope split apart during colonoscopy.Fda safety report id# (b)(4).

• Brand Name: CODMAN NEEDLE HOLDER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CODMAN / SYMMETRY SURGICAL GMBH
• MDR Report Key: 8821941
• MDR Text Key: 152174286
• Report Number: MW5088311
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2019

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 Catalogue Number: 36-2017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• 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 Outcome(s): Other
• Patient Age: 30 YR