MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLACK

Model Number	48345T-02
Medical Device Problem Codes	Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the sureform 45 black reload; however, the customer reported that the reload is not available for return.A review of an image provided by the customer was consistent with staples not releasing from the reload pocket.The root cause of the failure mode cannot be confirmed without the returned device.A review of the videos provided by the customer was performed by an intuitive surgical, inc.(isi) clinical development engineer (cde).The review of the videos showed unformed and malformed staples within the patient.It also showed a fenestrated bipolar forceps (fbf) instrument had an unformed staple in its jaw and then the jaw was moved further back into the patient's cavity.When the jaw of the fbf reappeared, the staple was no longer there.It is unknown if the staples were retrieved from the patient¿s anatomy.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, there was a problem with stapling the colon using the sureform 45 and 60 staplers with the sureform green 45 and 60 reloads.Stapling of the colon was not successful, and charging stopped halfway, preventing normal use of the device.There was a message on the da vinci console noting, "tissue too thick for stapling" despite normal tissue size.There was no patient consequence, but they noted that it was a very complicated situation at the time.Prior to calling technical support, the site already tried to use two instruments with blue and black reloads.The reporter stated that the surgeon was experienced with this kind of instruments/use.When the surgeon was using the stapler, both stapling and cutting ended mid-course, stated the caller.The intuitive surgical, inc.(isi) technical support engineer (tse) found nothing relevant in the logs.The tse asked the customer to reseat the sterile adapter (sa) prior to retrying with the sureform stapler, but the behavior remained.The caller stated that the robotic part of the procedure was now completed.The procedure was continuing as planned.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information: the reported event involved sureform stapler 60 (p/n: 480460 / lot: 82230731) and sureform staple5 45 (p/n: 480445 / lot: t18230918).The stapler reload colors that were used throughout the procedure were blue, green, and black.The surgeon selected the black reload due to tissue thickness, although the tissue did not appear overly thick.Several fires occurred in a row, even at the end, and the stapler worked only partially.The surgeon was stapling the lower rectum, targeting non-calcified tissue that had been exposed to radiation or chemotherapy, with no tissue tension or bunching.The issue involved partial fires, with no tissue being pushed forward or jaws opening unexpectedly.There were no malformed staples, exposed blades, missing staples, or gaps in the staple line, but it was unclear if the reload was stuck to the tissue.No obstructions were encountered, and the surgeon may have fired over an existing staple line.Buttress material was used, and no clamping issues or bleeding were observed.Five reloads were needed to complete the stapling, and the procedure was completed.The reloads and instruments are not available for return, but photos and videos were provided for review.The surgeon described the situation as unpleasant, with the stapler jamming repeatedly and indicating tissue thickness issues, despite the tissue not being overly thick.Ultimately, a good anastomosis was achieved.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20459132
• Report Number: 2955842-2024-20622
• Device Sequence Number: 20781947
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(17)260531(10)K10240509
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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: 48345T-02
• Device Catalogue Number: 48345T
• Device Lot Number: K10240509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male