MAUDE Adverse Event Report: MEDICON EG REPOSITION FORCEPS

Catalog Number	713.30.05
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Fields d1, d2 and d4 have been amended due to corrected information received from the initial reporter.
Additional Manufacturer Narrative
Fields d2 and d3 have been amended.

• Brand Name: REPOSITION FORCEPS
• Common Device Name: REPOSITION FORCEPS
• Manufacturer (Section D): MEDICON EG; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 9881092
• Report Number: 8010099-2020-00001
• Device Sequence Number: 14377585
• Product Code: GEN
• UDI-Device Identifier: 04046826119430
• UDI-Public: 04046826119430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 713.30.05
• Device Lot Number: 11AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020; 02/24/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 03/27/2020; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention