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 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps (part# 471205-17 | lot# k10220418 0028) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.At this time, it is unknown what caused the thermal damage to occur.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 is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during central processing, the fenestrated bipolar forceps had a defective plastic insulation.The procedure was completed with no reported injury.The site also confirmed there were no fragments in the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no cable broken.The defective plastic isolation referred to a burn/damage at the extremity of the fenestrated bipolar forceps.A possible arcing from a monopolar curved scissors (mcs) may have happened, however it could not be confirmed.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint "defective plastic insulation." failure analysis found the primary failure of bipolar yaw pulley thermal damage to be related to the customer reported complaint.The instrument was found to have thermal damage on the bipolar yaw pulley.The bipolar yaw pulley exhibits localized melting damage at the base of one of the grip tips.Electrical continuity was performed and passed.No damage to the conductor wire was observed.Root cause of this failure is attributed to mishandling/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: 15135308
• MDR Text Key: 296942597
• Report Number: 2955842-2022-13254
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K10220418
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/01/2022

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: K10220418 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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 Age: 62 YR
• Patient Sex: Male