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

Model Number 471205-17

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer reported a physical damage on the fenestrated bipolar forceps (fbf) instrument.The fbf instrument was replaced.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no issue.The instrument did not collide with any other instrument or tool.There was no arcing.The customer confirmed that no fragment fell inside of the patient.There was no patient injury.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps (fbf) instrument involved with this complaint and completed the device evaluation.Failure analysis replicated the reported complaint.Failure analysis found the primary failure of a broken conductor wire at proximal end to be related to the customer reported complaint.For clarification, the instrument failed the electrical continuity test because of a broken conductor wire at the main tube/roll gear junction.As a result, energy activation would not work when activated on the system.The root cause of broken conductor wire was attributed to a manufacturing issue.Additional observation, which was not reported by site and not related the reported complaint, was that the instrument was found with thermal damage at the bipolar yaw pulley.Black char marks were observed.Any material missing is likely to be thermally induced rather than mechanically induced.No insulation damage was observed on the conductor wire at the wrist assembly.The root cause of this thermal damage was attributed to mishandling or misuse.No image/video investigation required as no image or video clip for the reported event was submitted for review.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) 2022 via system serial# (b)(4).There were 5 uses remaining after this last usage.A review of the procedure log showed the site performed this radical extraperitoneal without lymphadenectomy prostatectomy surgical procedure on (b)(6) 2022 via system serial# (b)(4).This complaint is being reported due to the following conclusion: the fbf instrument had conductor wire damage at the proximal end at the main tube/roll gear junction.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.In addition, thermal damage at the bipolar yaw pulley is evidence of 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.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: g3, g6, h2, and h4.Analysis information can be found in the following field: h10.Additional analysis was performed on the fenestrated bipolar forceps instrument by an advanced failure analysis engineer.Initial findings were both confirmed.The fenestrated bipolar forceps instrument was further inspected but no other damage was observed.The root cause of the broken conductor wire in the proximal end was attributed to manufacturing, and the root cause of the thermal damage to the yaw pulley was attributed to the user mishandling or misuse.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 15595354
• MDR Text Key: 301645636
• Report Number: 2955842-2022-14544
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K10220404
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: K10220404 0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Sex: Male