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	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the clip application issue, an investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A review of the instrument log for the medium-large clip applier instrument (part number 478053-04| lot number k10220425 0009) associated with this event has been performed.Per this review of the logs, the medium-large clip applier instrument was used in procedure on 10-nov-2022 via system serial# sl0946.The instrument was last used on 21-nov-2022 on system sl0946 and there were 55 uses remaining after this usage.No image or video was available for review.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.This complaint is considered a reportable malfunction due to the following conclusion: per the description of the complaint, the clip applier may have incurred a failure mode that is known to impact clip application effectiveness.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.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the medium-large clip applier instrument clip was not fixed and the instrument could be closed.The customer completed the procedure robotically with a laparoscopic clip applier.The procedure was completed with no patient injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the medium-large clip applier instrument was inspected prior to use with no abnormality noted.When the surgeon used the instrument to clamp on the tissue bundle, the clip remained inside the instrument.The issue occurred for one or two times and the clip did not fall into the patient.The tissue bundle was less than 10 mm.The customer did not return the instrument as the instrument was used afterwards and it worked normally.

• 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: 15956083
• Report Number: 2955842-2022-15828
• Device Sequence Number: 6655516
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220425
• 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
• Report Date (Section B): 11/10/2022

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: K10220425 0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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