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

Model Number 470327-12

Device Problems Difficult to Remove (1528); Failure to Eject (4010)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.Intuitive surgical, inc.(isi) received the medium-large clip applier instrument associated with this complaint, and failure analysis (fa) investigation was completed.The customer reported complaint was replicated and confirmed during the fa investigation.The medium-large clip applier instrument failed the clip test, due to misapplication of the clip.The instrument was placed and driven on an in-house system, where it passed the recognition and engagement tests.The instrument was able to retain the clip through engagement, but it could not release the clip as commanded.Commonly, the loss of functionality to apply a clip is attributed to either a damaged grip cable or misaligned grips.The instrument was found to have a bent grip, and the tip did not align with the other grip.Bent grips with an offset < 0.05¿ are attributed to damage during use, as moderate misalignment of grip tips can be due to grasping either hard tissue/objects or collisions with other instruments.Per a review of the site's system logs for the reported procedure date, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that during a da vinci-assisted distal gastrectomy procedure, the medium-large clip applier instrument was used to place a clip onto an unspecified artery, however, the clip did not come off of one side of the jaws.Although the jaws closed completely to apply the clip, the jaws of the instrument could not be removed without removing the surrounding tissue as well.It was explained that the clip was attached to both the tissue (on one side) and the jaws of the instrument (on the other side).The jaws were not stuck onto the vessel.The tissue immediately surrounding the clip was excised with a 3rd party harmonic instrument; the amount of excised tissue equated to a few millimeters of the vessel on either side of the jaws, and it did not have a significant impact on the outcome of the procedure.This was initially thought to be a temporary issue caused by tissue penetration; however, a similar event occurred once more.The second instance also occurred on an unspecified artery, and a similar amount of tissue was removed again.When the jaws of the instrument were examined, it was confirmed that the jaws were misaligned.The surgeon discontinued the use of the instrument, and the procedure was completed with a new medium-large clip applier instrument.The instrument was inspected prior to use, and no damage or anything out of the ordinary was observed.No other issue with the medium-large clip applier instrument occurred, such as unintuitive motion.There was no unexpected bleeding as a result of this issue.The customer confirmed that medium-large (ml) clips were used with the medium-large clip applier instrument at the time of the event.The target vessel was confirmed to be smaller than 10mm in diameter.The medium-large clip applier instrument had been used at least once prior to the incident; however, the exact number of uses was unknown.There was reportedly no impact on the patient as a result of this issue; however, details regarding their current status are unknown.The surgeon has no concerns regarding long-term complications as a result of this issue.

• 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: 18066496
• MDR Text Key: 327301245
• Report Number: 2955842-2023-19764
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112465
• UDI-Public: (01)00886874112465(11)221014(10)K11221016
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: K11221016 0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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