MAUDE Adverse Event Report: INTUITIVE INTUITIVE FENESTRATED BIPOLAR FORCEPS

Model Number 420205-13

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

A fenestrated bipolar forceps had one of its "jaws" break off and fall into the pt during the surgery.At which point, the broken fenestrated bipolar forceps was removed and replaced with a new fenestrated bipolar forceps.The broken off "jaws" was retrieved and removed from the pt without any pt harm noted.

• Brand Name: INTUITIVE FENESTRATED BIPOLAR FORCEPS
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE ; sunnyvale CA
• MDR Report Key: 6800886
• MDR Text Key: 82999045
• Report Number: MW5071642
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-13
• Device Lot Number: N10170426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 81 YR
• Patient Weight: 59