MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; BIPOLAR CAUTERY CORD

Model Number 470384-03

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Event Description

It was reported that during a vinci-assisted surgical procedure, when the monopolar curved scissors and maryland bipolar forceps instruments were introduced, and the monopolar and bipolar cables were connected, no energy was passed to the instruments.The cables were replaced; however, the issue persisted.The surgeon made the decision to convert the procedure to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: upon encountering the energy issue, the customer re-started the erbe, checked the cables, and exchanged to another pair of activation cables; however, the energy connection remained unsuccessful.An isi field service engineer (fse) during a maintenance visit had advised the customer to acquire new activation cables.A visual inspection was performed, and damage was noted on one cable.No patient harm or injury was reported.The surgeon undocked from the da vinci system and continued the procedure laparoscopically.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the bipolar energy cable involved with this complaint and completed the device evaluation.Failure analysis investigation could not reproduce or verify external event to be related to the customer reported complaint.The electrical continuity was performed and passed.The cable was connected to an in-house system and placed on an in-house system.The cable pass energy recognition.Energy delivery test was performed and passed.The cable was fully functional.An additional observation not reported by site: a visual inspection was performed, and the cable was found to have insulation damage.Part of the cable was found to have insulation damage, exposing the wires inside.The cable was returned with a foreign material on the cable.Isi also received the monopolar energy cable involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.An electrical continuity was performed and failed.An additional observation not reported by site: a visual inspection was performed, and the energy cable was found to have electrical tape on part of the cable.The electrical tape appears to have melted onto the cable and was unable to be removed during in-house testing.The cable was evaluated further and found with a broken white electric cable.The black electrical tape was removed to identify a slit two inches below the p2 connector and broken wire.This is the root cause of the reported failed energy delivery during use with monopolar instrument.The broken wire would result loss electrical path for current to travel from erbe to the instrument.There were no signs of arcing at the location of the damage.

• Brand Name: NONE
• Type of Device: BIPOLAR CAUTERY CORD
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17015837
• MDR Text Key: 316760527
• Report Number: 2955842-2023-14964
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00886874112601
• UDI-Public: (01)00886874112601(10)VL172801
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K133167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470384-03
• Device Catalogue Number: 470384
• Device Lot Number: VL172801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES