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

Catalog Number 420205

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

During the operative procedure, the surgeon was using a fenestrated bipolar forcep- a robotic arm of the da vinci system.After using the device on and off, the device started to stick to tissue.Multiple attempts were made by staff to clean and lubricate the device, but it did not help to improve the forcep functioning properly.A new device was then opened to the surgical field and the new device worked properly and surgery was completed without any harm to the patient.Per surgeon and staff, the device "was creating too much energy, sticking to tissue regardless of cleaning and lubricating." manufacturer response for fenestrated bipolar forcep, fenestrated bipolar forcep (per site reporter).Device was given to the manufacturer's supplier rep.

• Brand Name: ENDOWRIST FENESTRATED BIPOLAR FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7489766
• MDR Text Key: 107469609
• Report Number: 7489766
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 420205
• Device Lot Number: N10171031099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 87