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	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the medium-large clip applier was not holding the clip.The jaws would not close.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-ups attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the medium-large clip not holding the clip, 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.The medium-large clip applier instrument was analyzed and found the functional test failed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The clip test was performed and failed.The instrument was not fully functional.The complaint regarding medium-large clip applier 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.Image(s) and/or video clip(s) associated with this reported event were not submitted for review.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).This issue can be resolved by using an alternate instrument to complete the procedure.This complaint has changed to a reportable malfunction due to the following conclusion: failure analysis confirmed a failed clip test.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.

• 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: 16438505
• Report Number: 2955842-2023-10886
• Device Sequence Number: 19620535
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220904
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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: K10220904 0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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