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

Model Number	478053-04
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted general surgical procedure, the medium large clip applier instrument had inadequate clamp issue and failure in releasing the clip.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: it was inspected prior to use with no damage observed.The event occurred when they were clipping the duct and the clip was open but it would not release from the arm after closing the clip.User took a new instrument to continue.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting that the medium large clip applier instrument had inadequate clamp issue and failure in releasing the clip, an investigation is in progress.An rma was issued to evaluate the intuitive surgical, inc.(isi) device.Intuitive surgical, inc.(isi) is pending receipt of a da vinci product to perform failure analysis.This complaint is considered a reportable malfunction due to the following conclusion: per the description of the complaint, the medium large clip applier instrument may have incurred a failure mode that is known to impact clip application effectiveness.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.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci medium-large clip applier instrument to perform failure analysis.The medium-large clip applier instrument was analyzed and was found to have a functional test failure.The medium-large clip applier instrument failed the clip test due to misapplication of the clip (e.G., the instrument passes engagement and was able to retain the clip through engagement but could not apply the clip).The complaint regarding inadequate clamp issue and failure to release the clip was confirmed by failure analysis, which indicates that the device did contribute to the customer-reported issue.The probable root cause of difficulty applying a clip is attributed to either a damaged grip cable or misaligned grips leading to a loss of functionality.The clip applier instrument failed the clip test due to misapplication of the clip (e.G., the instrument passes engagement and able to retain clip through engagement but cannot apply the clip).

• Brand Name: SINGLE-SITE
• Common Device Name: CLIP APPLIER, MEDIUM-LARGE
• 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: 16369108
• Report Number: 2955842-2023-10662
• Device Sequence Number: 8023397
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• 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,Followup
• Report Date (Section B): 01/19/2023

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: 478053-04
• Device Catalogue Number: 478053
• Device Lot Number: K10220605 0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown