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

Model Number 470172-16

Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)

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

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley on the distal end.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test thermal damage was observed near the conductor wire-yaw pulley entry.The housing was removed from the back end, and no damage was found.The root cause for the broken conductor wire is attributed to a component failure.Additional observations that were not reported by the site were also identified.The instrument was found to have damage to the conductor wire¿s insulation.The insulation exhibited thermal damage.The insulation exhibited signs of melting, however, no pieces were missing.The conductor wires were exposed, however no wires were damaged.The root cause of the damaged conductor insulation is attributed to a component failure.The instrument was found to have thermal damage on the bipolar yaw pulley.The yaw pulley showed signs of charring and localized melting the base and on the exterior of the grips.The thermal damage to the yaw pulley is indicative of arcing.The damage measured 0.025" x 0.070" in length.The root cause for this failure is attributed to a component failure.A review of the site's complaint history does not reveal any related complaints involving this product or this event.A review of system logs for system (b)(4) with a procedure date of (b)(6) 2021, confirmed a maryland bipolar forceps (pn# 470172 - 16 / lot # n10201006 - 0210) was exchanged with another maryland bipolar forceps (pn# 470172 - 16 / lot # n10201006 - 0068) during this procedure.The instrument has a maximum of 10 uses.The alleged event occurred on the 4th use of the instrument.There were 6 more uses remaining.Based on the additional information obtained from failure analysis investigations, this complaint is being reported due to the following conclusion: the instrument had conductor wire damage with no evidence of user mishandling or misuse.Thermal damage at or near a conductor wire breakage is evidence of 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 radical prostatectomy with lymphadenectomy surgical procedure, the metal cable at the tip of the maryland bipolar forceps instrument was broken and there was a procedure delay of 10 minutes.The procedure was completed with a back-up instrument with no reported injury.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12531246
• MDR Text Key: 273286634
• Report Number: 2955842-2021-11201
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N10201006
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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: N10201006 0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES