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

Model Number	420227-11
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the pk dissecting forceps 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 additional information is obtained.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 instrument log for the instrument (pn 420227-11/lot # n11191202 752) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4).The instrument had no uses remaining after last use.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the instrument had conductor wire damage.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.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 prior to starting a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the power cable of the pk dissecting forceps instrument was torn.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information can be found in the following fields: d9, g3, g6, h2, and h3 failure analysis investigation can be found in the following fields: h6 and h10 intuitive surgical, inc.(isi) received the pk dissecting forceps involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported complaint.Failure analysis found the primary failure of the broken conductor wire to be related to the customer reported complaint.The pk dissecting forceps instrument was found to have a broken conductor wire at the yaw pulley at the distal end.The conductor wire was broken at the grip-crimp location and the root cause was attributed to a component failure.

• Brand Name: ENDOWRIST
• Common Device Name: PK DISSECTING FORCEPS
• 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: 13614959
• Report Number: 2955842-2022-10389
• Device Sequence Number: 20096495
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N11191202
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061260
• 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): 02/01/2022

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: 420227-11
• Device Catalogue Number: 420227
• Device Lot Number: N11191202 752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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: Male