MAUDE Adverse Event Report: ENDOCLOSE BERCI FORCEP; ENDOSCOPE AND/OR ACCESSORIES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2018

Event Type  Injury  

Event Description

During closure of the abdomen, the endoclose berci forcep was introduced into the abdomen and after which it was observed that the sharp point (lower jaw) of the instrument was missing.The abdomen was visually scanned with the laparoscope to look for the lower jaw, it was not seen.The incision site was examined and the complete lower jaw was found in the subcutaneous tissue.

• Brand Name: ENDOCLOSE BERCI FORCEP
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• MDR Report Key: 8046620
• MDR Text Key: 126880153
• Report Number: MW5081139
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 89