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

Model Number 470172-16

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the maryland 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 provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The maryland bipolar forceps instrument looks like having a broken conductor wire.A review of the site's complaint history does not reveal any related complaints involving this product or this event.A review of the device logs for the maryland bipolar forceps (part# 470172-16 | lot/serial# n101905270060) associated with this event has been performed.Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4).There were 1 uses remaining after this last usage.This complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument conductor wire was damaged.The 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 a da vinci-assisted prostatectomy surgical procedure, the maryland bipolar forceps (mbf) instrument became detached and was unable to coagulate.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the cable was strongly frayed, maybe even completely cut.The damaged cable is the black cable.The patient demographic information was requested, but not provided.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, and h3 evaluation information can be found in the following fields: h6, and h10 intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.Fa found the primary failure of broken conductor wire to be related to the customer reported complaint.The maryland bipolar forceps instrument was found to have a broken conductor wire at the yaw pulley at the distal end.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage were observed.The root cause is attributed to a component failure.An additional finding not reported by the site was also identified: the maryland bipolar forceps instrument was found to have various scratch marks removed on the main tube.The scratch marks were 0.140¿ - 0.958¿ in length and were not aligned with the tube axis.The root cause of the scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MARYLAND 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: 14220991
• MDR Text Key: 290182423
• Report Number: 2955842-2022-11260
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N10190527
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N10190527 060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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