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

Model Number	48360T-08
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sureform 60 black reload accessory involved with this complaint and completed device evaluation.Failure analysis (fa) could not replicate/confirm the customer reported complaint.A visual inspection noted no damage was found.The reload was not fired.The sureform 60 stapler instrument involved with this complaint was also returned and completed device evaluation.Fa was able to confirm but not replicate the reported complaint.The instrument was found to have repeated clamping failures based on review, but was not able to be replicated in-house.The stapler instrument was installed a total of 8 times, and clamping failures occurred on installs 1, 2, and 7.It was noted the clamp history shows 10 incomplete clamps, 7 aborted, and 18 attempts.No image or procedure video was provided for review.A review of the system logs for the event date of (b)(6) 2020 has been performed by an isi post market surveillance specialist and the following was observed: there were no observed events in the system logs that would suggest a product issue and the logged events are in line with normal system functionality.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted pulmonary segmentectomy surgical procedure, tissue was stuck to the stapler/reload after firing due to an unknown cause.As a result, the procedure was converted to traditional laparoscopic surgery.The patient experienced bleeding, which the surgeon resolved with electrocautery.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the sureform 60 stapler indicated that the tissue was too thick, even after using the black stapler reloads.The target tissue was reported as lung and there was no tissue tension or tissue bunching during the stapler clamping sequence.The procedure was converted to traditional laparoscopic surgery.An error message: "tissue too large" was generated when the stapling issue occurred.Intuitive surgical, inc.(isi) obtained the following additional information from the site¿s robotics coordinator: the procedure was converted to traditional laparoscopic surgery because the issue occurred towards the end of the case and the surgeon didn't want to open up a new stapler instrument.The stapler successfully fired a few times, then would either fire successfully during the case or not fire at all.The stapler did not partially fire and there were no malformed staples.After firing, the patient's tissue would stick to the stapler.The surgeon used the stapler's manual release knob (mrk) to separate the stapler from the patient's tissue.Bleeding was observed during the procedure and blood loss volume was noted to be less than 750 ml and the surgeon used electrocautery to stop the bleeding.No other injuries were reported to occur.The reporter was not sure if the bleeding experienced by the patient was related to the reported stapler issue.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLACK
• 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: 14847888
• Report Number: 2955842-2022-12516
• Device Sequence Number: 20032111
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360T-08
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 115 KG