MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the pk dissecting forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint "cable is broken".For clarification, the instrument was found to have damage of the conductor wire¿s insulation.This failure is commonly caused by mishandling/misuse, such as collision of the instrument with a sharp object.Site history review: a review of the site's complaint history does not show any additional complaints related to this product.System log investigation: a review of the instrument log for the pk dissecting forceps (pn: 420227-11, batch-sequence: n11191021-234) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2020 on system (b)(4).The alleged event occurred on the final use of the instrument.Image/video review: no investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.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.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The alleged event occurred on the final use of the instrument.Thus, the instrument was not expired at the time.This report has been generated in response to fda inspectional observations dated 06-mar-2020.
Event or Problem Description
It was reported that during central processing, the pk dissecting forceps instrument was found to have a broken cable.There was no report of patient involvement.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10469035
• Report Number: 2955842-2020-10809
• Device Sequence Number: 2476110
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N11191021
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: 420227-11
• Device Catalogue Number: 420227
• Device Lot Number: N11191021 234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/28/2020
• 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