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

Model Number 480460-09

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.The product has not been returned to intuitive surgical, inc.For evaluation.Per a review of the site's system logs for the reported procedure date, no log information was available, as the procedure was not captured by the system logs.

Event Description

It was reported that during a da vinci-assisted gastric bypass procedure, blood began to ooze from an entire staple line made with a sureform 60 stapler instrument.This occurred after stapling for some time.The surgeon used coagulation to resolve the bleeding, and they sutured the entire staple line; these interventions caused a delay of at least 25 minutes or more.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the sureform 60 stapler instrument associated with this complaint, and a failure analysis (fa) investigation was completed.Fa did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on the in-house system; it was installed with a cannula seal and an in-house drape, and it passed engagement 3 out of the 3 times that it was installed.The instrument passed initialization and the recognition and engagement tests multiple times.It moved intuitively, with full range of motion in all directions, and the jaws opened and closed properly.The instrument clamped, fired both a green and a blue sureform 60 stapler reload, and unclamped successfully.A visual inspection was performed, and no damage was observed.No logs were available for review.There was no problem detected.Isi contacted the site and the following additional information was provided: the system is not connected to onsite at all.The instrument and accessories were inspected prior to use, and no issues were observed.It was confirmed that the staple line bled along the entire line of staples.The estimated amount of unexpected blood loss as a result of this issue was not recorded; however, no blood transfusions were required.The bleeding was resolved with cautery, using the fenestrated bipolar forceps instrument, and the surgeon sutured the entire length of the staple line; no other medical interventions were required.The target tissue was the stomach; there was no tissue tension or bunching, and the tissue had not been exposed to radiation or chemotherapy prior to the procedure.There was no tissue damage as a result of this issue.At the time of the event, the surgical task being performed was "gastric bypass." the surgeon believed that the sureform 60 stapler instrument caused or contributed to the bleeding, as the bleeding was only along the staple line.The procedure was completed robotically.The patient did not experience any postoperative complications, and they are currently healthy and recovered.A malfunction of the sureform 60 stapler instrument did not occur.The reload involved with the event was blue; the surgeon chose the appropriate reload color depending on the corresponding tissue thickness.All of the stapler fires involved in the creation of the gastric pouch and along the gastric remnant were involved with the reported event.The stapler performed the stapling action without any errors or faults.The bleeding began after the stapling process was completed successfully.The event did not involve a failure to fire, a partial fire, tissue being pushed forward/dragged during the firing process, the jaws opening/releasing during the firing sequence, or the reload deploying staples unexpectedly.The event did not involve malformed or unformed staples, an exposed blade, staples missing from the staple line, holes/gaps in the staple line, or tissue becoming stuck to the reload.No error messages were generated at the time of the event.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws.The surgeon did not fire over an existing staple line.No buttress material was used.There were no clamping issues prior to firing the stapler reload.There was no unplanned tissue removal due to the stapler issue.The stapling was done successfully, and no back-up stapler was required.Only after the stapling did the surgeon use other instruments to overcome the bleeding and secure the staple line with sutures.

Manufacturer Narrative

Advance failure analysis investigations were performed on this sureform 60 stapler instrument (lot number: l10221103-074) and the initial fa findings were confirmed.There was no damage to any components nor increased friction observed; no mechanical issue was identified.Based on visual inspection, and functional testing of the device, the complaint cannot be confirmed nor replicated.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: 18428441
• MDR Text Key: 331787969
• Report Number: 2955842-2023-21841
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)L10221103
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 480460-09
• Device Catalogue Number: 480460
• Device Lot Number: 0724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/08/2024; 03/06/2024
• Supplement Dates FDA Received: 01/31/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Single Use?: Yes
• 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.