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	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, arm 1 was locking up and saying it was not ready and to remove the instrument to continue.The caller received a call from the surgeon after the case was completed.The caller stated that after closing the single-site medium-large clip applier instrument onto the cystic artery it would not allow the surgeon to open the jaws back up.The customer was able to manually open jaws to release the instrument.Customer then swapped over a suction irrigator from arm 3 and had similar problems with it locking up and displaying the message the arm was not ready and to remove the instrument.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed error logs and found multiple instrument engagement errors on universal surgical manipulator (usm) 1 during the time of the procedure, error 31009, instrument sensors missing.The procedure was completed with no reported injury.Isi followed up with the initial reporter on and obtained the following additional information: the instrument was inspected prior with no noted damage.The type of clips used were medium-large weck clips.The issue occurred on the first clip application attempt.There are no photos or videos available.No tissue was excised due to the event.There was no bleeding due to the event.The patient demographic information was provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the single-site medium-large clip applier instrument to perform failure analysis (fa).Fa could not replicate the customer reported complaint.A review of the system logs showed 4 - 31009 errors relating to recognition failure (instrument sensors missing.A tool was fully detected, but then lost 1 or more but not all of the tool sensors for 3+ seconds on usm1).The instrument was placed on an in-house system.The instrument passed the recognition and engagement tests.The instrument passed the clip test.The grips opened and closed properly.
Additional Manufacturer Narrative
The single-site medium-large clip applier instrument has been evaluated by the failure analysis engineer (fae) team.Fae partially confirmed the initial findings.The logs were reviewed and prior to the recognition failure, it was found that the logs indicated that a grip release wrench tool was used on this instrument during the procedure, confirming the customer reported complaint.The instrument was placed on an in-house system and passed recognition and engagement.The grips were able to open and close properly.A clip was installed into the grips and clip application was tested and passed.
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: 18213660
• Report Number: 2955842-2023-20479
• Device Sequence Number: 5671810
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220731
• 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): 10/31/2023

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: K10220731 0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 02/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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 Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White