MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 470405-06

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis neither confirmed nor replicated the reported issue that there was ¿difficulty inserting/removing the instrument.¿ the instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.There was no difficulty inserting and removing the instrument.The instrument was found to have damage of the conductor wire¿s insulation.System log investigation: a review of the instrument log for the force bipolar instrument (pn: 470405-06, batch-sequence: t10191031- 0042) associated with this event has been performed.Per a review of the logs, the force bipolar was last used on (b)(6) 2020 on system sk1415.The alleged event occurred on the 6th use of the instrument.Site history review: a review of the site's complaint history does not show any additional complaints related to this product.Image/video review: no image/video investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported because damage to the conductor wire of the instrument could lead to unintended electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.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 instrument was returned with 4 uses remaining and, therefore, was not expired.Implant date is blank because the product is not implantable.Initial reporter is blank because it is unknown if a report was submitted to the fda by the initial reporter.This report has been generated in response to fda inspectional observations dated 06-mar-2020.

Event Description

It was reported that during a da vinci-assisted umbilical hernia repair surgical procedure, the customer experienced difficulty in inserting/removing the force bipolar instrument.The procedure was completed with no reported patient harm, injury, or adverse outcome.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed-up with the initial reporter, who corroborated the patient outcome, but indicated that patient demographic and related information is not available.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10469348
• MDR Text Key: 220989365
• Report Number: 2955842-2020-10824
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)T10191031
• Combination Product (y/n): N
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: T10191031 0042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/05/2020
• 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.