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

Model Number 470172-16

Device Problems Break (1069); Fracture (1260)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported during a da vinci-assisted surgical procedure, the instrument had a broken cable. The procedure was completed as planned with no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) performed follow-up to request additional information related to the event, but no further details could be provided.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the maryland bipolar forceps instrument and performed a device evaluation. Failure analysis confirmed the reported issue. The instrument was found to have the main tube broken. A piece measuring approximately 0. 071¿ x 0. 105¿ was not returned with the instrument. The root cause of broken instrument main tube is attributed to mishandling/misuse. The following was found during the device evaluation, but was not related to the reportable finding: the instrument was found to have a broken conductor wire at the yaw pulley. 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 of this failure is attributed to a component failure. The instrument was also found to have multiple input disks cracked. Hairline cracks were found on grip input disks. The root cause of cracked instrument input disks is typically attributed to mishandling/misuse. 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 device logs for the maryland bipolar forceps (part# 470172-16 | lot-sequence# n10190924-0220) associated with this event has been performed. Per this review of the logs, the maryland bipolar forceps was last used on 11/19/2020 during a benign hysterectomy on system serial# sk0709. No investigation required as no image or video clip for the reported event was submitted for review. This complaint is considered a reportable event due to the following conclusion: failure analysis identified that a fragment had detached/broken off from a portion of the device that enters the patient and was returned. Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure. While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient. Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable. The expiration date for section d4 is not applicable. Field d6 is blank because the product is not implantable. Field e4 is blank because it is unknown if a report was submitted to the fda by the initial reporter. Fields g5 and g7 are not applicable.

• 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: 14191083
• MDR Text Key: 299010796
• Report Number: 2955842-2022-11220
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)N10190924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470172-16
• Device Catalogue Number: 470172
• Device Lot Number: N10190924 0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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 Treatment Data

Date Received: 04/23/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES