MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number 48360B

Device Problem Failure to Form Staple (2579)

Patient Problem Injury (2348)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

4315- isi has not received the sureform stapler instrument or the sureform60 reload involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the reload and instrument are returned (post failure analysis evaluation) or if additional information is received.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2020.The logs show an error 22030 indicating a firing failure on the sureform 60, part number: 480460-09, lot number 1904080397.The reload color on which the firing failure occurred could not be confirmed.The error 22030 gets logged on sureform when the firing fails at the end of travel (>95% completion).Image/video review - no images or videos were shared for the event.As of (b)(6) 2020, a review of the site's complaint history does not reveal any related complaints involving this event.This complaint is reported due to the following conclusion: it was reported that after completion of a da vinci-assisted revisional bypass surgical procedure, the patient returned to the hospital due to a postoperative leak.It was reported that during the procedure, the surgeon had fired on stomach tissue with a sureform60 stapler instrument with a blue sureform60 reload installed on it.On the third staple fire, the sureform 60 stapler instrument had allegedly cut, but did not staple.The surgeon had completed the procedure with a handheld stapler instrument.The patient was in the hospital for ten days.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date in is not applicable.Is blank because the product is not implantable.Is blank because it is unknown if the initial reporter submitted a report to the fda.Is blank because there was insufficient product information available to determine the manufacture date.Is not applicable.

Event Description

It was reported that after completion of a da vinci-assisted revisional bypass surgical procedure, the patient returned to the hospital due to a postoperative leak.It was reported that during the procedure, the surgeon had fired on stomach tissue with a sureform 60 stapler instrument with a blue sureform60 reload installed on it.On the third staple fire, the sureform 60 stapler instrument had allegedly cut, but did not staple.The surgeon had completed the procedure with a handheld stapler instrument.The patient was in the hospital for ten days; however, it is unknown if the patient was in hospital for ten days from the original admission, or, ten days after the patient returned to the hospital due to a leak.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10947068
• MDR Text Key: 219582033
• Report Number: 2955842-2020-11295
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48360B
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Hospitalization