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

Model Number 470327-12

Device Problem Difficult to Open or Close (2921)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the medium-large clip applier instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was placed and driven on an in-house system.The instrument failed the clip test.The clip was unable to fully close on the test tube.Root cause of this failure is attributed to mishandling/misuse.The clip applier instrument was found with one grip bent.The damage was found near the base of the clip groove, causing a.042" offset at the tips.As a result, the clip could not fully close onto the test tube during the clip test.The root cause of bent-severely instrument grips -tips is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws.A review of the device logs for the medium-large clip applier (part# 470327-12| lot-sequence# n10210111-0083) associated with this event has been performed.Per this review of the logs, the medium-large clip applier was last used on (b)(6) 2021 during a cholecystectomy on system serial# (b)(4).No investigation required as no image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis confirmed a failed clip test.Deficiencies in clip application may lead to inadequate hemostasis.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 during a da vinci-assisted cholecystectomy procedure, the instrument not release clip when applied.The procedure was completed as planned with no report of patient harm, adverse outcome or injury.

• 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: 14247457
• MDR Text Key: 299401621
• Report Number: 2955842-2022-11307
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)210107(10)N10210111
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: N10210111 0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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 Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES