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 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the fenestrated bipolar forceps be returned for failure analysis to be performed, but the instrument has not yet been received.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site 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 on system sk0248 for a ventral hernia tapp surgical procedure.There are 10 uses remaining.This complaint is being reported due to the following conclusion: it was alleged that the fenestrated bipolar forceps instrument had conductor wire damage.The damaged/broken 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.

Event Description

It was reported that during central processing, the fenestrated bipolar forceps instrument was observed to have the insulated wire that was damaged (small cracks).The procedure was completed with no reported injury.On (b)(6) 2022, intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed the issue was identified during central processing.The instrument was inspected for damage prior to central processing.The insulation of the instrument was observed to be broken.The customer also confirmed that the instrument was inspected prior to a procedure and no damage of insulation was noted.There were no arcing, loss of cautery or collusion with other instrument.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps (fbf) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.Fa found the primary failure of damaged conductor wire insulation to be related to the customer reported complaint.The instrument was found to have damage to the conductor wire¿s insulation.Visual inspection found the wire not exposed.The instrument passed electric continuity test.The instrument was placed and driven 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.The grips opened and closed properly.The instrument was fully functional and released energy normally.The root cause is attributed to a component failure.

• 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: 14247176
• MDR Text Key: 290535827
• Report Number: 2955842-2022-11301
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)K11211122
• 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: 04/01/2022

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: K11211122 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male