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

Model Number	478053-04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A return material authorization (rma) has been issued and intuitive surgical, inc.(isi) has requested to have the medium-large clip applier instrument be returned for evaluation; however, the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.Based on the current provided information, this complaint is considered a reportable event due to the following conclusion: it was alleged that the medium-large clip applier was not able to apply the clips on the tissue and the clip fell into the patient.The clip was retrieved during the same procedure with no patient injury.At this time, it is unknown what caused the incident to occur.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer manipulated the medium-large clip applier instrument but was not able to apply the clips on the tissue.The clip fell into the patient¿s cavity and was retrieved during the same procedure.The procedure was completed with a backup instrument of different kind.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no abnormality.During the procedure, the surgeon could not apply the weck hem-o-lok medium-large ligating clip on the vessel, so the clip fell into the patient.The issue occurred as soon as the customer started to use the instrument.It was not related to clip opening after closure of the clip.The vessel or tissue bundle was less than the specified diameter suggested in the instructions for use (ifu) (13mm).The clip was retrieved during same procedure and confirmed with visual inspection.Additional surgical procedure and post-operative tests were not performed.The instrument did not collide with any other instruments or other hard material.Upon final removal of the instrument, the wrist was straightened, and the surgical staff did not feel any resistance upon removal of the instrument through the cannula.Both instrument and cannula had no other damage after the event occurred.The patient had no injury or harm and has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the clipping failure and that the clip fell into the patient, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis and the medium-large clip applier instrument was analyzed.Failure analysis investigations confirmed the customer reported complaint and found the primary finding of a failed functional clip test to be related to the customer reported complaint.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).An additional observation not reported by site was that this instrument¿s grip tips were not moving intuitively, i.E.They were not following the master tool manipulator (mtm) input commands smoothly.More precisely, the instrument motion was imprecise (normal but non-exact).The complaint regarding clipping failure was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of loss of functionality to apply a clip is attributed to either a damaged grip cable or misaligned grips.

• 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: 16169793
• Report Number: 2955842-2023-10083
• Device Sequence Number: 8557712
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220418
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 478053-04
• Device Catalogue Number: 478053
• Device Lot Number: K10220418 0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 01/14/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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