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	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the medium-large clip applier instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "malfunctioned during procedure." failure analysis found the primary failure of clip test failed to be related to the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grip-clip test was performed and failed.The housing was removed for inspection and found no damage.Additionally, the instrument's main tube was found bent.The bending damage was located mainly at the proximal end of the main tube.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a medium-large clip applier instrument malfunctioned.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) contacted the original reporter and obtained the following information: the customer thinks the issue is with the arm and not the instrument, but she is not sure.

• 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: 16925327
• Report Number: 2955842-2023-13240
• Device Sequence Number: 6805364
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)N10200120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/20/2021

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: N10200120 0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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