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

Model Number 470205-17

Device Problem Arcing (2583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Isi has not received the fenestrated bipolar forceps instrument involved with this complaint.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.A log review was performed for the fenestrated bipolar forceps instrument reported in this complaint (pn: 470205-17/ n111910210059) and the following was found: the instrument was last used on (b)(6) 2020.The instrument had 8 uses remaining and was not used for any subsequent procedures.No error would appear in the logs for this type of reported issue.No photo or video was provided by the site for review.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided, this complaint is being reported due to the following conclusion: the instrument was observed to have a burn mark on the jaw with no evidence or claim of user mishandling or misuse.The damage described is indicative of potential instrument arcing, although the user noted that no arcing was noticed.Although no patient harm occurred, if this malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that after a da vinci-assisted low anterior resection surgical procedure, the fenestrated bipolar forceps instrument was observed to have a burn mark on the jaw.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no arcing during the procedure.The procedure was completed with no reported injury.The burn on the instrument was discovered in the washing process after the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have thermal damage of the bipolar yaw pulley at the base of the grips.Melted char marks were present.Any material missing from the damage of the yaw pulley is likely thermally induced rather than mechanically induced.The known common cause of this failure is mishandling/misuse.Based on the failure analysis investigation results, this complaint has been re-evaluated as a non-reportable complaint based on the following conclusion: this failure mode did not cause or contribute to a death or serious injury, there is no other malfunction to consider, and per failure analysis investigation, the energy-related issue was caused by user mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint remains a reportable product problem.Please disregard the previous h10 statement indicating that this complaint is no longer mdr reportable.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10216146
• MDR Text Key: 232760043
• Report Number: 2955842-2020-10618
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N11191021
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N11191021 0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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.