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

Model Number 470172-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/22/2020

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted nephroureterectomy surgical procedure, the jaws of the maryland bipolar forceps was not working, so the patient side assistant removed the instrument and found that it was damaged.A fenestrated bipolar forceps instrument was used to complete the procedure with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: it was confirmed there was no arcing witnessed, no injury, and the issue was that the jaws did not open properly.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the maryland bipolar forceps (mbf) instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed and replicated the reported complaint.The primary failure of broken pitch cable was found to be related to the customer reported complaint.The mbf instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.As a result, non-intuitive motion could be observed.The pitch cable breakage occurs when the tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip length, grip torque, and manufacturing tolerances are a few variable, which could influence the pitch cable failure.The root cause of this failure is attributed to component failure.The instrument had 7 uses remaining.A log review was conducted, which resulted in the following findings: the logs show the customer last used the maryland bipolar forceps (mbf) instrument part# 470172-16 lot# t10190603-0079 on (b)(6) 2020 during a nephroureterectomy procedure with system sk1648.The instrument had 7 lives remaining.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or video clip for the reported event was submitted for review.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the jaws of the maryland bipolar forceps instrument were not working.Per completed failure analysis, the instrument was found to have a broken pitch cable.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.

• 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: 13117148
• MDR Text Key: 290814275
• Report Number: 2955842-2021-11833
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112281
• UDI-Public: (01)00886874112281(10)T10190603
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: T10190603 0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2019
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES