MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ENT CEPS; FORCEPS

Lot Number 002110

Device Problem Failure to Cut (2587)

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

Event Date 09/21/2020

Event Type  malfunction  

Event Description

Entceps was being used and not cutting per provider.New supply opened and worked fine.Fda safety report id# (b)(4).

• Brand Name: ENT CEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10586025
• MDR Text Key: 208755452
• Report Number: MW5096850
• Device Sequence Number: 1
• Product Code: HTD
• 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: 09/22/2020

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 Lot Number: 002110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2020
• 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: 7 YR
• Patient Weight: 25