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

Model Number	420318-05
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The small grasping retractor instrument has been returned and evaluated by the failure analysis team.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.The missing crimp was approximately 0.046¿ x 0.032¿.A review of the small grasping retractor instrument log for pn# 420318-5; sn#: (b)(4) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system sh1681.The alleged event occurred on the 1st use of the instrument.A review of the site's complaint history does not show any additional complaints related to this product.No image, or video clip for the reported event was submitted for review.No additional technical review was required based on the complaint.This complaint is being reported because 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 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, the small grasping retractor instrument's internal wire broke intraoperatively.A backup instrument of the same type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer, and obtained the following additional information: the instrument was inspected prior to use.The surgeon was retracting the colon when the reported problem occurred.No instrument collisions occurred.

• Brand Name: ENDOWRIST
• Common Device Name: SMALL GRASPING RETRACTOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10512769
• Report Number: 2955842-2020-10883
• Device Sequence Number: 17057968
• Product Code: NAY
• UDI-Device Identifier: 00886874111802
• UDI-Public: (01)00886874111802(10)N10181114
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 420318-05
• Device Catalogue Number: 420318
• Device Lot Number: N10181114 979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/10/2020
• 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