MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SMALL GRASPING RETRACTOR

Model Number 470318-10

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the 8mm small grasping retractor instrument popped up. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the 8mm small grasping retractor instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/confirmed the customer reported complaint. Failure analysis found the primary failure of the broken pitch cable to be related to the customer reported complaint. The small grasping retractor 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. The pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material. The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics. Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure and the root cause of this failure is attributed to a component failure. The root cause of the broken pitch cable was attributed to a component failure and related to device design. An additional observation not reported by the site was also identified. The small grasping retractor instrument was found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 045¿ - 0. 311" in length and were not aligned with the tube axis and the root cause of the scratch marks /abrasions on the instrument main tube is typically attributed to mishandling/misuse. The housing was removed from the back end of the instrument and found the flush tube guide dislodged. The flush tube guide did not exhibited physical damage, no pieces were missing. The flush tube does not exhibited any damage. The root cause of the dislodged flush tube guide is attributed to mishandling/misuse. A review of the instrument log for the small grasping retractor (470318-10/ n102106070243) associated with this event has been performed. Per logs, the small grasping retractor was last used in a procedure on (b)(6) 2021 on system (b)(4). The alleged instrument had 5 uses remaining after the last procedural use. A review of the site's complaint history found that there were no other complaints for this product or this event. No image or video of the procedure was provided for review. This complaint is being reported based on the failure analysis findings. A small grasping retractor instrument is designed with two pitch cables, each with a crimp at the distal end. If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient. 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: SMALL GRASPING RETRACTOR
• 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: 13027045
• MDR Text Key: 283954777
• Report Number: 2955842-2021-11765
• Device Sequence Number: 1
• Product Code: NAY
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470318-10
• Device Catalogue Number: 470318
• Device Lot Number: N10210607 0243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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 Treatment Data

Date Received: 12/17/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES