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

Model Number	420318-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the small grasping retractor involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The instrument was found to have a broken pitch cable at the distal end.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 conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables that can influence pitch cable failure.A review of the instrument log for the instrument (pn 420318-07/lot # n10190520 460) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2021 on system sh0659.The instrument had 3 uses remaining after last use.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.No image or procedure video was provided for review.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 or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, movement on the small grasping retractor instrument did not work.The instrument had a loose cable.The procedure was completed using a back-up instrument with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12186136
• Report Number: 2955842-2021-10804
• Device Sequence Number: 3357285
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10190520
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 420318-07
• Device Catalogue Number: 420318
• Device Lot Number: N10190520 460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1