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

Model Number 48360B

Device Problems Use of Device Problem (1670); Failure to Form Staple (2579); Failure to Cut (2587)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/29/2021

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted bariatric revision surgical procedure (from a band to a gastric bypass), the surgeon reported that the sureform 60 (sf60) stapler instrument with a blue sureform 60 reload was installed during the first fire.The stapler clamped down on the stomach with no issues.However, when he pressed the yellow pedal, the blade jammed and dragged the tissue and did not cut tissue.The staples did not form correctly.There was a three centimeter myotomy (hole) on both sides of the staple line (the gastric pouch and the remnant gastric tissue).The surgeon noticed a clip from the previous lap band surgery embedded on the tissue he was stapling.The surgeon thinks the clip might have gotten caught in front of the blade and caused the stapling issue.The surgeon repaired the defect on the gastric pouch, stapling medial to the incomplete staple line with the same sureform 60 stapler instrument and a new blue sureform 60 reload.As a result, the size of the pouch was reduced.The surgeon oversewed the defect on the remnant gastric tissue.Although this stapling issue resulted in a smaller pouch, he does not believe that will affect the surgical outcome or if the patient will have any long-term effect.The patient is reported to be recovering well.The surgeon confirmed the following: the reload was discarded, he did not use buttress material, the (b)(4) stapler instrument was used for the remainder of the procedure with no issues, there is no video recording; however, there is an image that was provided for review.

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure can be attributed to stapling over a metal clip.Isi has requested the sureform 60 stapler instrument and the blue sureform 60 reload associated with this event to be returned for failure analysis evaluation; however, it was confirmed the products were discarded.If additional information is received, a follow-up mdr will be submitted.The sureform 60 user manual provides the following: "warning: make sure that no obstructions (such as clips, staples, bone or other hard objects) are between the jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples." a review of the stapler logs for the sureform 60 stapler instrument associated with this event has been performed.The logs show that sureform 60 stapler instrument (part # (b)(4), lot #t91210809-0063) was installed 9 times and fired 7 reloads (2 blue, 1 white, 2 blue, 2 white, in that order).All firings were completed per the logs.Firing #3 (white) had a couple of pauses for compression, and firings #6 and #7 (both white) also had 1 pause each.The remaining firings did not have any pauses.The instrument had 1 incomplete clamp that occurred on an install that did not result in a firing.There were no other incomplete clamps.An isi clinical development engineer performed a review of the provided image and noted the following: the image provided is of tissue that is not transected by the stapler.Malformed staples were scattered around the tissue that appears to be dragged/torn by the stapler.A review of the site's complaint history did not identify any other complaints related to this product/event.This complaint is being reported due to the following conclusion: during a da vinci-assisted bariatric revision surgical procedure, the surgeon stapled across metal clips from a previous surgery resulting in a three centimeter myotomy (hole) on the gastric tissue.Although the staples were deployed from their pockets, they did not close on the gastric tissue and the gastric tissue was dragged and torn.The staples were dumped.As a result, the surgeon had to repair the gastric pouch, stapling medial to the incomplete staple line reducing the size of the gastric pouch.The surgeon closed the remnant gastric tissue hole with sutures.Although there was an issue with stapling, it was determined that the stapling issue was secondary to stapling over a metal clip from a previous surgery.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 is not applicable.The product is not implantable.Insufficient product information was provided in order to obtain the date of manufacture.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an "adverse event and product problem" rather than just an "adverse event" as previously reported due to a stapling issue when using the sureform 60 stapler and a blue sureform 60 reload, which could potentially be related to a product problem.It was reported that the surgeon pressed the yellow pedal, the blade jammed and dragged the tissue and did not cut tissue.The staples did not form correctly.If additional information is received, a follow-up mdr will be submitted.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60 RELOAD BLUE
• 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: 13315616
• MDR Text Key: 287540925
• Report Number: 2955842-2022-10109
• Device Sequence Number: 1
• Product Code: GDW
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48360B
• Device Catalogue Number: 48360B
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White