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

Model Number 471205-17

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the 8mm fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of damaged conductor wire insulation to be related to the customer reported complaint.For clarification, the fenestrated bipolar forceps instrument was found to have damage to the conductor wire¿s insulation at the distal end.The conductor wire was exposed as a result.The instrument passed the electrical continuity test.No signs of thermal damage were observed.The root cause of this failure was attributed to a component failure.A review of the instrument log for the fenestrated bipolar forceps (471205-17/k112107120243) associated with this event has been performed.Per logs, the fenestrated bipolar forceps instrument was last used on (b)(6) 2021 on system (b)(4).The instrument had 1 use remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video of the last procedure was provided for review.This complaint is being reported due to the following conclusion: during failure analysis testing, the fenestrated bipolar forceps instrument was found to have conductor wire damage with exposed internal wires and a passed electrical continuity test.The damaged conductor wire has 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.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted surgical procedure that the 8mm fenestrated bipolar forceps instrument had broken or loose cable.The procedure was completed with no reports of patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 13102388
• MDR Text Key: 290536564
• Report Number: 2955842-2021-11828
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11210712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: K11210712 0243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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.