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

Model Number	48360T-09
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reload was found to have the knife exposed within the knife track.The reload was found to have a firing failure.Intuitive has received the second sureform stapler 60 instrument associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint of "tissue pushout".Upon visual and microscopic inspection, no damage was found at the wrist assembly.No damage was observed to the i-beam assembly.The instrument was placed on system.No initialization failures or errors/faults occurred during in-house testing.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.Clamp and fire test passed on test sheet.Staple formation on test sheet was proper.The first black reload tissue pushout event will be reported against patient identifier (b)(6).The green reload tissue pushout event will be reported against patient identifier (b)(6).Logs show sureform stapler 60 instrument part number 480460-09, ln l10230113-0017, was used first, and it was installed on the system 3x and fired 2 reloads (1 green, followed by 1 black).On install 1, the first two clamp attempts were successful, but were followed by a firing failure.The firing stopped at about 95% completion, after a duration of about 39 seconds.The instrument was unclamped and re-installed.On install 2, no clamping or firing was attempted.On install 3, the first clamp was aborted by the user at about 49% completion.The next clamp was successful but was followed by a firing failure.The firing stopped at about 90% completion, after a duration of 53 seconds.The user then initiated a force fired, however that was also incomplete.The force fire stopped at about 99% completion after an additional 2 seconds.This force fire failure shows in the logs as error code.The instrument was then removed and not used again in the procedure.Logs show sureform stapler 60 instrument part number 480460-09, ln l10230113-0014, was installed on the system 1x and fired 1 black reload.On the only install, the system failed to detect the reload color, and the user manually selected the black reload.The first clamp was aborted by the user at about 64% completion.The next clamp was successful but was followed by a firing failure.The firing stopped at about 71% completion, after a duration of 37 seconds.The instrument was then removed and not used again in the procedure.There were no additional stapler related errors in the logs.A clinical development engineer (cde) reviewed the images, partially transected tissue with a pile of malformed and unformed staples was visualized, along with some bleeding.The images do appear to be consistent with tissue pushout though difficult to confirm without video.This is commonly attributed to stapling across an existing staple line.The sureform stapler instrument user manual has warnings against stapling over obstructions and/or existing staple lines as it may lead to tissue damage or staple line disruption like we see in these images.
Event or Problem Description
It was reported that during a da vinci-assisted bariatric revision surgical procedure while using two sureform 60 stapler instruments, pushout events occurred.The surgeon was stapling the antrum of the stomach, and tissue pushouts had occurred.These occurred on fires one, two, and three with one green reload and two black reloads.All three reloads experienced tissue too thick errors.The surgeon fired the green reload and the black reload with the first sureform60 stapler instrument.The surgeon switched to a second sureform60 stapler instrument and fired with a black reload, but the issue persisted.The surgeon did not encounter any obstructions between the instrument's jaws.There were no clamping issues before firing.The surgeon had to over-sew the posterior gastrotomy that was made as the result of the stapling issues.The surgeon opened an echelon stapler, and his bedside assistant fired the stapler three times with three green reloads over the existing staple line to correct the issue.The procedure was completed robotically.The patient was discharged from the hospital postoperatively on day two.No post-operative complications were experienced.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The second black sureform60 reload was returned with the blade exposed around 3/4 the length of the reload.This reload was observed to have cartridge damage; the damage maybe due to hard objects dragging along the reload surface during firing.The reload blade was found to have indentations; likely caused by firing across hard objects.The second sureform60 stapler instrument used during this event was received.The stapler passed in-house testing and performed without 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: 18246215
• Report Number: 2955842-2023-20785
• Device Sequence Number: 6582027
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 48360T-09
• Device Catalogue Number: 48360T
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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 Sex: Unknown