MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; TIP COVER ACCESSORY

Model Number 400180-14

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The monopolar curved scissors (mcs) tip cover accessory will not be returned for evaluation as site has discarded the mcs tip cover accessory.Therefore, the root cause of the customer reported failure mode cannot be 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 or this event.No image or procedure video was provided for review.Verification of the accessory product via system logs cannot be performed because accessory device product details are not captured in the system log.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.This complaint is being reported due to the following conclusion: the mcs tip cover accessory was reportedly damaged with no evidence or claim of user mishandling/misuse.In the event the mcs tip cover accessory is compromised, it is possible for energy to discharge in an area other than the instrument tip.Per the i&a user manual "it is important to exercise caution when using a energized endowrist monopolar curved scissors 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.Although there was no report of patient injury related to the reported event, the reported failure mode could cause or contribute to an adverse event if the failure were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date in section is not applicable.Field is not applicable because the product is not implantable.The information for blank fields in section is not available.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the insulation on the monopolar curved scissors (mcs) instrument was damaged and an orange marking can be seen.There were no fragments that fell inside of the patient's anatomy, and no adverse effects or injury to the patient.The procedure was completed with no reported injury.Intuitive surgical (is) contacted the site and obtained the following additional information regarding this event: the mcs tip cover was discarded and will be not returned for review.Patient demographics and medical history cannot be released due to hospital policy.No further details have been received as of the date of this report.

• Brand Name: NONE
• Type of Device: TIP COVER ACCESSORY
• 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: 12993551
• MDR Text Key: 285830306
• Report Number: 2955842-2021-11736
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/15/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES