MAUDE Adverse Event Report: MEDICON EG REPOSITION FORCEPS

Catalog Number 713.30.05

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

The instrument set available to the surgeon during the procedure had been incorrectly prepared, substituting the sharp-tipped forceps for a blunt-tipped reposition forceps of the same size that the surgeon was accustomed to using.

Event Description

During a sternal fixation procedure, a bone holding forceps with sharp tips was mistakenly used instead of a blunt-tipped reposition forceps, causing bleeding of the manubrium and requiring bovie cauterization.Ultimately the procedure was completed as planned.

Manufacturer Narrative

Fields d1, d2 and d4 have been amended due to corrected information received from the initial reporter.

Manufacturer Narrative

Fields d2 and d3 have been amended.

• Brand Name: REPOSITION FORCEPS
• Type of Device: REPOSITION FORCEPS
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 9881092
• MDR Text Key: 191267736
• Report Number: 8010099-2020-00001
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 04046826119430
• UDI-Public: 04046826119430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 713.30.05
• Device Lot Number: 11AA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 02/24/2020; 02/24/2020
• Supplement Dates FDA Received: 03/27/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention