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

Model Number 470179-19

Device Problems Thermal Decomposition of Device (1071); Scratched Material (3020)

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

Event Date 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the monopolar curved scissors (mcs) instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the instrument logs showed the mcs instrument (part# 470179-19 / lot# k13211101-0038) was last used on (b)(6) 2022 on system (b)(4) for a gastric bypass (roux-en-y) surgical procedure.The instrument had 8 uses remaining after last use.Image of the mcs instrument related to this event were received.A review of the provided image was performed by an isi failure analysis engineer.The following additional information was provided: it does not look like there is thermal damage to the instrument.It¿s difficult to tell from the picture what the mark the customer circled is.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the monopolar curved scissors instrument exhibited signs indicative of thermal damage.At this time, it is unknown what caused the thermal damage to occur.While there was no harm or injury to the patient, the reported failure mode could likely 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.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.

Event Description

It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, a piece of the protective insulating sheath was missing from the monopolar curved scissors (mcs).The site noted this damaged implied burns at a distance.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter; however, they were unable to provide any additional information regarding the complaint.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument tube extension exhibits signs of scratch marks/abrasion.Tube extension scratch marks measured roughly 0.107¿ - 0.133¿ in length.The root cause of scratch marks/abrasions on the instrument tube extension is typically attributed to user mishandling, such as excessive contact with abrasive or hard surfaces during transport or reprocessing, or during cover installation/removal.

• 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: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 15127006
• MDR Text Key: 296838588
• Report Number: 2955842-2022-13218
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(11)211028(10)K13211101
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K220023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: K13211101 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES