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

Model Number 471205-17

Device Problems Thermal Decomposition of Device (1071); No Device Output (1435)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The fenestrated bipolar forceps instrument was requested to be returned, but it has not yet been received by isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps instrument (pn# 471205-17 / lot# n14210504-0094) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 1 hour 15 minutes.The alleged event occurred on the 4th use of the instrument with 10 remaining.A review of the site's complaint history does not reveal any related or duplicate complaint involving this product and/or this event.No images or procedure videos were provided for review.This complaint is being reported due to 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 part of the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that after a da vinci-assisted surgical procedure completed with no reported injury, cautery damage at the tip of the fenestrated bipolar forceps instrument was discovered in the central sterile services department.The fenestrated bipolar forceps is a multiple-use electrosurgical endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: after the completion of the procedure the instrument was not inspected for any damage; however, the thermal damage was identified prior to reprocessing.It was reported that no interoperative instrument collisions occurred and no arcing was observed.The instrument is available to evaluation; however, no photographic images of the instrument are available.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D11 - intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.The instrument was found with thermal damage at the yaw pulley.Black char marks were observed.Any material missing is likely to be thermally induced rather than mechanically induced.Root cause is attributed to mishandling / misuse.Failure analysis found the primary failure of thermal damage to the bipolar yaw pulley to be related to the customer reported complaint.The electrical continuity test still passed and there was no insulation damage observed to the conductor wire.

• 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: 13559197
• MDR Text Key: 285814240
• Report Number: 2955842-2022-10278
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(10)N14210504
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: N14210504 0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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.