MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MEDIUM-LARGE CLIP APPLIER

Model Number	430005-52
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the medium-large clip applier instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.No image or procedure video was provided for review.A review of the instrument log for the medium-large clip applier instrument (part# 430005-52| lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the medium-large clip applier instrument was last used on (b)(6) 2022 via system serial# (b)(4).There were 99 uses remaining after this last usage.This complaint is being reported based on the following conclusion: the jaw of the medium-large clip applier instrument would not open.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 thyroidectomy surgical procedure, the jaw of the medium-large clip applier instrument would not open.A backup instrument of the same kind was used to continue the procedure.There was no report of fragment(s) falling inside the patient.The procedure was completed with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use with no abnormality.The instrument jaws were not opened but were not grasping the tissue so the customer did not use the instrument release key (irk).The instrument was in used for vessel ligation and removed with no issue.The vessel was less than 10 mm in diameter.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The patient had no injury/harm.The customer confirmed that the medium-large clip was used and no fragment fell inside of the patient.There was no unexpected tissue removal nor bleeding.Photographic images of the device(s) or a video recording of the procedure were not available for isi review.Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.
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 replicated and confirmed the customer reported complaint ¿the jaw of the medium-large clip applier instrument was not opened.¿ failure analysis found the primary failure of dislodged pivoting clamp to be related to the customer reported complaint.For clarification, the housing was removed from the back end of the instrument and found the pivoting clamp on the grip rod to be dislodged.The clamp did not exhibit any physical damage.As a result, the grips cannot open or close properly.The distal end was inspected, no snake wrist cables were damaged.The clip grips and grip knob did not exhibit any physical damage.The root cause for the dislodged pivoting clamp is typically attribute to user mishandling/misuse.Additional observation(s) not reported by site was that the instrument was found to have corrosion on one or more clamping pulleys in the backend.The root cause of corroded/contaminated instrument clamping pulleys is typically attributed to user mishandling/misuse, most commonly caused by improper cleaning/ reprocessing techniques.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the rfe procedure log showed the site performed this thyroidectomy surgical procedure on (b)(6) 2022 on system serial# (b)(6).
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The medium-large clip applier instrument was further investigated and tested by the failure analysis engineer (advanced failure analysis).The actuating the grip knob does not result in the jaws opening and closing.Upon removal of the shell, it was found that the grip rod pivot clamp was dislodged from the grip sector gear.The grip sector gear also exhibited scratch marks, likely from when the pivot clamp was dislodged.The root cause for a dislodged grip rod pivot clamp is typically attributed to user mishandling/misuse.The grip/drive rod was also found to be bent, towards the proximal end where the threading of the rod ends.The root cause of the bent rod is also attributed to user mishandling/misuse.The failure modes observed could have been caused by improper reprocessing/handling techniques, or if excessive force was applied to the jaws.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: MEDIUM-LARGE CLIP APPLIER
• 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: 14785065
• Report Number: 2955842-2022-12311
• Device Sequence Number: 5935540
• Product Code: NAY
• UDI-Device Identifier: 00886874114292
• UDI-Public: (01)00886874114292(10)S10190319
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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,Followup,Followup
• Report Date (Section B): 05/23/2022

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: 430005-52
• Device Catalogue Number: 430005
• Device Lot Number: S10190319 0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 07/28/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/29/2022; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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