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

Model Number 470318-10

Device Problem Material Fragmentation (1261)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Isi received the small grasping retractor instrument involved with this complaint and completed the device evaluation. Failure analysis investigation replicated/confirmed the reported complaint. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from the clevis. 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 condition, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure. The root cause was attributed to a component failure and related to device design. Additionally, the instrument was found to have various scratch marks with light material removed on the main tube. This finding was not related to the reported failure and not reported by the customer. The scratch marks were 0. 042¿ ¿ 0. 298¿ in length and were not aligned with the tube axis. The root cause of scratch marks/abrasions is typically attributed to user mishandling. 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 instrument log was performed. Per the review, the following was confirmed: device material, lot#/serial #, and event date. The instrument was last used on (b)(6) 2021 on system sk2584. The instrument had 2 uses remaining after last use. Based on the information provided at this time, this complaint is being reported due to the following conclusion: this 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 into 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.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, a cable on the small grasping retractor instrument was torn while grasping intestinal tissue. A similar backup da vinci instrument was used to continue with the case. 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 date of this report.

• 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: 13102078
• MDR Text Key: 290073385
• Report Number: 2955842-2021-11825
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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: N10210405 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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: 12/28/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES