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	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy, the medium-large clip applier instrument would not pick up the clip from the cartridge and would not lock on tissue.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The medium-large clip applier was analyzed and found upon visual and microscopic inspection; no damage was found to the wrist assembly.No misalignment of grips was observed.Ligation clip was successfully installed on the instrument.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The grips clip test was performed and failed to close the ligation clip.Even with no object to clip on, the grips did not appear to fully close for clip action to occur.The complaint regarding clip application failure 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).A review of the instrument log for the medium-large clip applier (478053-04/n10210615-0015) associated with this event has been performed.Per logs, the medium-large clip applier was last used on 11/22/2022 on system sk3387, with 69 lives remaining.No investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported based on the following conclusion: failure analysis confirmed a failed clip test with the finding of a loose grip cable.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 product to perform failure analysis.The initial findings were confirmed.The instrument was placed on an in-house system and failed the clip test.The housing was then removed, and it was found that the screw at the rocker holding the push-pull rod assembly was loose.The loose screw likely caused the push-pull rod assembly to be unsecure and thus, unable to generate enough force to complete clip application.The root cause of this failure is attribute to a component failure.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 16040226
• Report Number: 2955842-2022-16090
• Device Sequence Number: 11996070
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)N10210615
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: N10210615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White