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

Model Number 470205-17

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.027¿ offset at the tips.The root cause of bent grip tips is attributed to mishandling.The instrument was also found to have thermal damage on the bipolar yaw pulley.The root cause of bipolar yaw pulley thermal damage is attributed to mishandling.The instrument was then found to have insulation damage on the conductor wire at the distal end.The insulation damage was located at the grip-crimp location on the bipolar yaw pulley.Electrical continuity was tested and passed.No material was missing.The root cause of insulation damage on the conductor wire is attributed to a component failure.A review of the instrument log for the fenestrated bipolar forceps (part # 470205-17 / lot # n11200330 0197) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system (b)(4) , with 2 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.This complaint is being reported because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent energy transmission to tissue other than intended via the exposed conductor wire.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 a da vinci-assisted cholecystectomy surgical procedure, the fenestrated bipolar forceps did not have sufficient grip.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11102285
• MDR Text Key: 235043740
• Report Number: 2955842-2020-11434
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112359
• UDI-Public: (01)00886874112359(10)N11200330
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/09/2020

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: 470205-17
• Device Catalogue Number: 470205
• Device Lot Number: N11200330 0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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
• Patient Age: 64 YR
• Patient Weight: 95