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

Model Number 470179-19

Device Problem Energy Output Problem (1431)

Patient Problem Bowel Burn (1756)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted and did not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.System error log review was not possible with the lack of system and instrument detail on file at this time.A review of the instrument logs was attempted for a procedure on (b)(6) 2021 on system sk3618 but there was no record of a procedure for dr (b)(6) and further log review could not be conducted at this time due to the lack of product information.Although an initial report described an ¿overabundance of heat¿ from an mcs instrument, there is no substantiated report of arcing and there is no evidence that the isi device caused or contributed to an adverse event or that the isi device malfunctioned in a way that could contribute to an adverse event if it were to recur and the alleged failure mode does not meet the criteria of a reportable malfunction.However, as a precautionary measure, the surgeon allegedly over-sutured a small burn on the bowel which is considered intervention that was outside of what was planned.At this time, the severity of the small bowel burn and the root cause of the bowel injury are unknown.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Lot #, serial #, udi #, and prod mfg date were unknown due to lack of product information.Implant date is blank because the product is not implantable.Initial reporter's address is blank because it is unknown if the initial reporter submitted a report to the fda.Pma/510(k), adverse event, recall, and correction/removal report number are not applicable.

Event Description

It was initially reported that during a da vinci-assisted sacrocolpopexy with hysterectomy procedure, the surgeon stated that the monopolar curved scissors instrument retained an ¿overabundance of heat which resulted in a small burn on the bowel¿.To resolve the issue, the surgeon, ¿over sutured the bowel for any leaks¿.The procedure completed robotically.The patient¿s current status was unknown.Intuitive surgical, inc.(isi) had reached out to the customer multiple times to obtain additional information but has not yet received a response.

• 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: 11548713
• MDR Text Key: 241654853
• Report Number: 2955842-2021-10295
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.