MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-04
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not yet received the large hem-o-lok 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.A log review was performed for the large hem-o-lok clip applier instrument reported in this complaint (pn: 420230-04/m10110606661) and the following was found: the instrument was last used on 01-jul-2020 on system sh1249.The instrument had 6 uses remaining and was not used for any subsequent procedures.No error would appear in the logs for this type of reported issue.No photo, or video was provided by the site for review.This complaint is being reported because a large hem-o-lok clip applier instrument failed to fully latch a clip closed or 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.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer stated that the large hem-o-lok clip applier instrument was unable to work and it cannot hold the clip correctly.The procedure was completed with no reported injury.No further details have been received as of the date of this report.
Additional Manufacturer Narrative
Additional information can be found in the following sections: d10, g4, g7, h2,h3, h6, and h10.4307 intuitive surgical, inc.(isi) received the large hem-o-lok clip applier instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The instrument was found to have a loose grip cable at the distal end.The root cause of this failure is attributed to a component failure.In addition, fa found that the instrument had a broken grip cable at the proximal end.The root cause of this failure is attributed to a component failure.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10744697
• Report Number: 2955842-2020-11130
• Device Sequence Number: 19630402
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)M10110606
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 420230-04
• Device Catalogue Number: 420230
• Device Lot Number: M10110606 661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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.