MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; FENESTRATED BIPOLAR FORCEPS

Model Number 420205-13

Device Problem Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

The fenestrated bipolar forceps instrument involved with this event has been returned and evaluated.During failure analysis, the instrument was found to have a severely bent grip, causing side to side misalignment of the grips.There was a 0.055" offset at the tips.Grip performance and energy activation performance was reduced since the distal tips no longer meet.The known common cause of this failure is mishandling/misuse.No signs of charring or black marks were observed at the grip assembly.The instrument passed the electrical continuity test.Device history record (dhr) review for the device involved with this complaint has been completed.No non-conformances were identified to be related to this complaint.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient experienced "tissue damage." as a result, the surgeon placed "surgical" material to repair the tissue.However, at this time, the root cause of the customer reported event is unknown.Based on an evaluation of the fenestrated bipolar forceps instrument, there is no indication that a malfunction of the instrument occurred.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tip of the fenestrated bipolar instrument caused "trauma" to the patient's tissue.On (b)(4) 2018, intuitive surgical, inc.(isi) obtained the following additional information from an or nurse who was informed of the reported event: during the da vinci-assisted surgical procedure, when the fenestrated bipolar forceps instrument was used, the patient allegedly experienced ¿ internal tissue damage.¿ at that time, the surgeon decided to place ¿surgical material¿ on the burnt tissue.The nurse confirmed there was no arcing observed and there was no change to the setting of the electrosurgical unit.There is no video recording of the procedure.The or nurse could not provide any additional details.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7362625
• MDR Text Key: 103204641
• Report Number: 2955842-2018-10090
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111642
• UDI-Public: (01)00886874111642(10)N10170113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420205-13
• Device Lot Number: N10170113 181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention