MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problems Crack (1135); Scratched Material (3020); Material Split, Cut or Torn (4008)

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

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) has not received the monopolar curved scissors (mcs) tip cover accessory for evaluation. The mcs instrument has been received, but evaluation has not been completed. Therefore, the root cause of the customer reported failure mode has not been determined. A follow-up mdr will be submitted following the completion of evaluation and 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. No image/photo was provided. The mcs instrument and the mcs tip cover accessory were not used on the patient because the issue was identified prior to use. Therefore, there is no log information available for the instrument. 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. Per the i&a user manual "it is important to exercise caution when using a energized endowrist mcs instrument to help avoid unintended contact with tissue adjacent to the area to be cauterized. " failure to follow these precautions will result in electrical arcs from the wrist and alternate site burns. This complaint is being reported based on the following conclusion: the mcs tip cover accessory was damaged in the dark gray section, with no evidence or claim of user mishandling/misuse. Although no patient harm occurred, and the instrument was not used on a patient, if this malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that at the beginning of a da vinci-assisted bladder neck suspension procedure, upon installation of the monopolar curved scissors (mcs) tip cover accessory, the operating room staff noticed that the black sheath covering the instrument was scratched. The instrument was not used on the patient. Another instrument was used to proceed with the case. The procedure was completed with no known impact or patient consequence reported. Intuitive surgical, inc. (isi) followed up with the customer to request additional information and obtained the following details on 30-july-2021. The issue was identified at the beginning of the procedure following the installation of the mcs tip cover accessory. It was unknown whether the installation tool was used. There was no exposed wire, and no signs of thermal damage. To avoid any risk of arcing, the instrument was not used on the patient. No image or video was available for review.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12352152
• MDR Text Key: 267626717
• Report Number: 2955842-2021-10974
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: N12201110 0673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 08/22/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES