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.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Correction: based on follow-up response and failure analysis investigation, the reported complaint of scratches were observed on the monopolar curved scissors (mcs) instrument and not the mcs tip cover accessory.D11- intuitive surgical, inc.(isi) has received the mcs instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the reported complaint.The mcs was found to have deep scratch marks, approximately 0.03" to 0.10" in length to the surface of the brown section of the tube extension with material removed.Material was missing.Any potential fragments from the brown section of the tube extension would not be retained by use of the mcs tip cover accessory for this mcs design.This failure is most commonly caused by mishandling/misuse, such as excessive contact with abrasive or hard surfaces during transport or reprocessing, or during tip cover installation/removal.A review of the instrument log for the monopolar curved scissors instrument (part #470179-19/lot #n12201110 0673) associated with this event has been performed.Per logs, the mcs instrument was last used on (b)(6) 2021 on system sl0526, with 6 uses remaining.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• 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
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• 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: Health Professional
• 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
• Date Manufacturer Received: 08/23/2021
• 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.; DA VINCI INSTRUMENTS AND ACCESSORIES