MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CLIP APPLIER, MEDIUM-LARGE

Model Number	478053-04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the medium-large clip applier instrument allegedly was unable to lock the clip.The user replaced to the backup instrument and continued the procedure with no further issue reported.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event from the hospital nurse: the instrument was inspected prior to use and no issue was identified.The instrument initially worked.The instrument was unable to apply the clip during actual clip application.The instrument was not damaged.The clip that was intended to be applied fell into the patient and was retrieved during the same procedure.
Additional Manufacturer Narrative
Based on the claim against the product by the customer regarding clip application failure and a fragment may have fell inside the patient, an investigation was completed to determine the cause of this reported event.Although the complaint regarding the issue was not confirmed by failure analysis since the instrument was not returned, the information gathered indicates that the device did contribute to the customer reported issue.Intuitive surgical, inc.(isi) has not yet received the instrument for failure analysis.Therefore, the root cause of the customer reported failure could not be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.The probable root cause of the clip application failure and clip subsequently falling inside the patient is currently undetermined.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.Additionally, it was alleged that the clip fell inside the patient during a da vinci assisted procedure.The clip was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the issue to occur.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the medium-large clip applier instrument for evaluation.The reported event was confirmed during failure analysis investigation.The 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).No physical damage was identified.
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: 16122197
• Report Number: 2955842-2022-16346
• Device Sequence Number: 6533342
• Product Code: NAY
• UDI-Device Identifier: 00886874113585
• UDI-Public: (01)00886874113585(10)K10220418
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478053-04
• Device Catalogue Number: 478053
• Device Lot Number: K10220418 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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