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 Foreign Body In Patient (2687)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported complaint.The clip applier instrument was found with one grip bent.The damage was found near the base of the clip groove, causing an offset at the tips.As a result, the clip could not be properly loaded on the grips and the clip test failed.The root cause of bent-severely instrument grips -tips is typically attributed to mishandling/misuse, such as excess force applied to instrument jaws.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the instrument log for the medium-large clip applier instrument (part number: 470327-12, lot number: n10201019-0044) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system sk4232.The instrument was used for 24 minutes.The instrument was used for 5 times during the procedure.The instrument had 60 uses remaining out of 100 max tool uses.No image or video clip was provided for the reported event.This complaint is considered a reportable event due to the following conclusion: per the description of the complaint, the clip applier incurred a failure mode that is known to impact clip application effectiveness.Deficiencies in clip application may lead to inadequate hemostasis.In addition, it was reported that clips fell inside the patient, and they were not retrieved.Blank mdr fields: relevant tests and patient's medical history were unknown.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the clips failed to clip onto the structures with the medium-large clip applier instrument.The clips fell inside the patient, and they were not retrieved.The customer used a backup instrument.The procedure was completed with no injury to the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter (da vinci coordinator) and obtained additional information: the surgeon used hem-o-lok, medium-large clips with the instrument.The clips were closed but they were not locked onto the vessel.The customer used a backup clip applier instrument.The vessel was not greater than 10 mm in diameter.There were no broken or loose cables noted on the instrument.The instrument was inspected prior to use with no damages noted.There was no adverse effect to the patient¿s tissue and there was no unexpected bleeding.The customer confirmed that fallen clips were not retrieved from the patient.

• 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: 13863113
• MDR Text Key: 293143957
• Report Number: 2955842-2022-10716
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(10)N10201019
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470327-12
• Device Catalogue Number: 470327
• Device Lot Number: N10201019 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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.
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic