MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. FENESTRATED BIPOLAR FORCEPS; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Lot Number N10170925-

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

During robot assisted laparoscopic inguinal hernia (lih) repair-surgeon was using fenestrated bipolar grasper to pull suture through tissue and one of two "arms" on grasper broke off inside patient.Piece was able to be retrieved.

• Brand Name: FENESTRATED BIPOLAR FORCEPS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 710 venture dr, suite 300; desoto trade center building 1; southaven MS 38672
• MDR Report Key: 7178773
• MDR Text Key: 96874758
• Report Number: 7178773
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: N10170925-
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR