MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problems Thermal Decomposition of Device (1071); Defective Device (2588)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported that during central processing that, the plastic end of the distal tip of the permanent cautery hook instrument is burned.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the damage was identified after reprocessing.The instrument was inspected before being reprocessed prior to the event.The damage to the instrument was noted in the sterile processing department (spd).

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of thermal damage to be related to the customers reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley.The conductor wire insulation was not damaged.The conductor wire was not broken.The instrument passed the electrical continuity test.The root cause of thermal damage on the instrument monopolar yaw pulley is typically attributed to mishandling and misuse.Additional finding not reported by site was that the instrument was found to have thermal damage on one of the distal clevis ears.The root cause of thermal damage on the distal clevis is attributed to misuse.A review of the instrument logs for the permanent cautery hook instrument (470183-14/k10220510 0052) associated with this event was performed.The instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Failure analysis confirmed the issue and the cause is attributed to mishandling and misuse.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.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 15263501
• MDR Text Key: 298277660
• Report Number: 2955842-2022-13593
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)220510(10)K10220510
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: K10220510 0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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