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

Model Number 471205-17

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the product be returned, but has not received the fenestrated bipolar forceps (fbf) for evaluation as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ 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.A review of the instrument log for the fbf instrument (part# 471205-17 lot n10210308-0091) associated with this event has been performed.Per logs, the fbf was last used on (b)(6) 2021 on (b)(4).A review of the provided image was performed by an intuitive surgical, inc.Failure analysis engineer (fae).Per fae, the yaw pulley appeared to have suffered thermal damage at the base of the grips.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the thermal damage to occur.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.

Event Description

It was reported that the fenestrated bipolar forceps was broken and melted under the grip.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the reporter to request additional information.However, as of the date of this report, no further information was provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: d9, g3, g6, h2, h3, h6 and h10.D02-intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps (fbf) associated with this complaint and completed investigations.Failure analysis investigations confirmed the reported complaint.The instrument was found to have charring and localized melting at the grip base between the grips.The instrument passed the electrical continuity test.The root cause is typically attributed to the mishandling/misuse, most commonly caused by insulation degradation and carbonized tissue creating a conductive path.An additional observation not reported by the site was also identified.The instrument was found to have damage to the conductor wire¿s insulation at the distal end.The conductor wire was exposed as a result.There was no thermal damage observed around the area of the damaged insulation of the conductor wire.The root cause of this failure 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12532987
• MDR Text Key: 273347873
• Report Number: 2955842-2021-11206
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N10210308
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/31/2021

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: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: N10210308 0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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; DA VINCI INSTRUMENTS AND ACCESSORIES