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

Model Number	420227-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
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 confirmed the customer reported complaint of "exposed wire." the instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.A site history review was performed and there were no related complaints identified.A system log review was performed and there were no error messages generated from the instrument usage.The instrument had three remaining lives, and it was not used in subsequent procedures.No images or videos of the event were provided for review.The customer reported complaint does not itself constitute an mdr reportable event.However, if a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall inside the patient.Although there was no patient injury, the product malfunction could cause or contribute to an adverse event if the failure were to recur.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the 8mm pk dissecting forceps instrument was found to have an exposed wire.The procedure was completed with no reported injury.

• Brand Name: PK DISSECTING FORCEPS
• Common Device Name: ENDOWRIST
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10077865
• Report Number: 2955842-2020-10505
• Device Sequence Number: 3184479
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10140328
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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: 420227-05
• Device Catalogue Number: 420227
• Device Lot Number: N10140328 087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1