MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number 400180-14

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The mcs tip cover accessory has not been returned to isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the product is returned (post engineering evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A system log review was performed, but no errors related to this event would exist in the logs.Based on the information provided at this time, this complaint is being reported because the mcs tip cover accessory reportedly had a tear and a hole in a unspecified location.Although there was no report of arcing or of patient injury, if this failure were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, a tear was identified on the monopolar curved scissors (mcs) tip cover accessory and a 1mm hole was observed below the tear.A backup accessory of the same type was used and the procedure was completed with no reported injury.The mcs tip cover accessory, when used as intended, provides insulation over a section of the endowrist mcs instrument so that radio frequency (rf) energy is only available at the instrument scissor tips.Intuitive surgical, inc.(isi) followed up with the initial reporter for additional information; however, no response has been received at this time.

Manufacturer Narrative

D02 - intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) tip cover accessory involved with this complaint and completed the product evaluation.Failure analysis investigation found tearing at the mouth on the distal end with material approximately 0.03" x 0.03" missing and not returned.The tear is not axially aligned with the mcs tip cover accessory and measures 0.17¿ in length.There are no signs of thermal damage present at the end of any tears.Tears at the mouth are most commonly caused by repeated thermal and mechanical stresses.Failure analysis found the primary failure of torn tip cover to be related to the customer reported complaint.Root cause is attributed to component failure.Based on the information provided at this time, this complaint is being reported because the mcs tip cover accessory presented evidence of tearing at the distal clear silicone tip with material missing.

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11611779
• MDR Text Key: 243720601
• Report Number: 2955842-2021-10348
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874111045
• UDI-Public: (01)10886874111045(10)M90201015
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Catalogue Number: 400180
• Device Lot Number: M90201015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/03/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 05/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES