MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MEDIUM-LARGE CLIP APPLIER

Model Number 470327-12

Device Problem Unintended System Motion (1430)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has received the medium large clip applier instrument and completed the failure analysis testing. The customer allegation of the tip being loose and moving in an unintended direction was not able to be replicated or confirmed through testing. The instrument did not exhibit a loose grip tip. The instrument was placed and driven on an in-house system and it moved intuitively in all directions. The clip test was performed and passed without any issues. The root cause of the customer's reported issue cannot be traced to the device. 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 for the medium-large clip applier instrument lot# n10191007 / sequence 0074 associated with this event has been performed. Per logs, the instrument was last used on the reported event date of (b)(6) 2021 on system sk1529. The instrument has 71 remaining usable lives with no subsequent use recorded. No procedure video or image was submitted to isi for review. This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the clip applier instrument moved with unintuitive motion (e. G. The instrument unexpectedly jerked/jumped/swung/bowed, moved in an unexpected/unintended/unknown way). Unintuitive motion could lead to subsequent tissue damage. 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 colorectal procedure, the user observed that the clip from the medium large clip applier instrument tip appeared to be "loose" and moved unintuitively.

• Brand Name: ENDOWRIST
• Type of Device: MEDIUM-LARGE CLIP APPLIER
• 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: 13115255
• MDR Text Key: 289961374
• Report Number: 2955842-2021-11832
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: N10191007 0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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 Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES