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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

An (b)(6) has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the fenestrated bipolar forceps instruments for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis) and/or if additional information is obtained.A review of the device logs for the fenestrated bipolar forceps (part# 471205-17| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2021 via system serial# (b)(4).There were 4 uses remaining after this last usage.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that the instrument smoked, arced, and melted with no evidence or claim of user mishandling or misuse.The allegation could be related to the potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date (2020 reports) is not applicable because the product is not implantable.Information for the blank fields in initial reporter name and address is not available.Fields pma/510k (2020 reports, adverse event, recall (if recall number is given) (2020 reports), and correction/removal number (2020 reports) are not applicable.

Event Description

It was reported that during a da vinci-assisted liver resection surgical procedure, the insulated sheath on the fenestrated bipolar forceps melted, which generated smoke and electrical arcing.The cable and instrument were replaced and the generator was set to 8.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) obtained the following additional information on (b)(6) 2021 regarding this event: the instrument was inspected prior to use, and no damage was observed.After arcing, the instrument was removed and the instrumentalist found that the instrument had melted.A gauge was not used to inspect the cannula.The arcing was observed from the jaws of the instrument.Cauterization was being performed when the smoke appeared.Bipolar energy was activated when the arcing event occurred.A monopolar cord was not connected to a bipolar instrument.Erbe generator bistouri was used with coagulation effect 8.The instrument had been in use for at least 2 hours prior to the arcing event.A monopolar curved scissors and cadiere forceps instrument were also in use when the arcing event occurred.The instrument tips did not collide with any other instrument or tool during procedure.The instrument tips were in contact with tissue as it was used to coagulate the liver.The instrument tips did not touch any staples, clips or sutures while energized and the jaws were possibly already contaminated by carbonized tissue prior to activating the instrument.It is unknown if the instrument was removed during the procedure and if the wrist was straightened.The root cause of the arcing event is unknown.A backup instrument was used and the coagulation effect was reduced.The patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.No photographic images of the device or a video recording of the procedure are available for review.

Manufacturer Narrative

D11 - 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 charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.The damage measures approximately 0.108" x 0.232" in length with no pieces missing.The grip cables and conductor wires were not damaged.No additional thermal damage was found on the instrument.The instrument was placed on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.An energy delivery test was performed and the instrument delivered energy successfully without signs of sparking, smoking or additional damage delivered to the yaw pulleys.The root cause of thermal damage between grips instrument bipolar yaw pulley is typically attributed to the user, most commonly caused by carbonized tissue creating a conductive path.During fa investigation, the instrument also identified a failure that was not reported by the site, and not related to the reported issue.The instrument was found to have a bent grip, causing vertical misalignment of the grips.There was a 0.036¿ offset at the tips.During in-house testing, the instrument was unable to open and close its grips properly or grip properly.The root cause of bent instrument grips tips is typically attributed to the user.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12243686
• MDR Text Key: 264028913
• Report Number: 2955842-2021-10875
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10201103
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N10201103 0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.; DA VINCI INSTRUMENTS AND ACCESSORIES.