MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; MONOPOLAR CAUTERY INSTRUMENT

Model Number 430007-55

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the sp monopolar cautery instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed and replicated the reported complaint.A visual inspection of the instrument found the electrical contacts were damaged at the distal end.The contacts were bent within the tube adapter.An electrical continuity test was performed and the instrument passed.The contacts were not broken and no pieces were missing.The root cause for the bent electrical contacts is attributed to user mishandling/misuse.Further investigation identified findings that ere not reported by the site.The sp monopolar cautery instrument tube adapter at the distal end was cracked.The crack measured approximately 0.136¿ in length.No pieces were missing.The root cause for the cracked tube adapter is attributed to user mishandling/misuse.In addition, the tube adapter was found to exhibit thermal damage on the distal end.The tube adapter exhibited localized melting, which is indicative of arcing.The location was at the center of the tube adapter.It was noted that the thermal damage covered the circumference of the tube adapter.The root cause for the thermal damage was not established.The instrument had 17 uses remaining.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.A log review was conducted, which resulted in the following findings: the logs show the customer last used the sp monopolar cautery instrument on (b)(6) 2021 during a radical tonsillectomy procedure on system sp0096.The instrument had 17 uses remaining.This last usage of the device was before the reported event date, indicating that the device did not pass recognition or the issue was identified before installation on the reported event date.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.No image or video clip for the reported event was submitted for review.Based on the information provided, this event is being reported due to the following conclusion: after a da vinci-assisted surgical procedure, it was alleged that the sp monopolar cautery instrument tip was damaged.Failure analysis confirmed and replicated the reported complaint and found localized melting on the tube adapter, which is indicative of arcing.While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 25 usages allotted to it, which are tracked by the da vinci surgical system.This reported issue occurred on the instrument's 8th usage and, therefore, had not expired.Implant date is blank because the product is not implantable.Initial reporter also sent report to fda?: is blank because it is unknown if the initial reporter submitted a report to the fda.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that after a da vinci-assisted radical tonsillectomy surgical procedure, the customer found that the monopolar cautery instrument tip was damaged.There was no reported injury or harm.Intuitive surgical, inc.(isi) has performed multiple follow-up attempts to obtain additional information from the customer concerning the reported event, but no further details have been received as of the date of this report.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D11, d15 - additional investigation was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The initial failure analysis findings were confirmed.It was noted that the cracking of the thread and bending of the contact was probably caused by improper installation of the sp monopolar cautery instrument prior to use.No firm cause could be assigned to the dried crust of material or local thermal damage.The root cause of the cracked tube adapter was attributed to user mishandling/misuse, while the thermal damage was not determinable.

• Brand Name: ENDOWRIST SP
• Type of Device: MONOPOLAR CAUTERY INSTRUMENT
• 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: 12493427
• MDR Text Key: 272104059
• Report Number: 2955842-2021-11145
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114315
• UDI-Public: (01)00886874114315(10)S10190919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 430007-55
• Device Catalogue Number: 430007
• Device Lot Number: S10190919 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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.