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

Model Number	48360T-08
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, there was a blade exposed event when the sureform stapler was used.There were no errors on system log review.This was the 2nd firing of this sureform 60 during the procedure and a black reload with buttress material was used.The stapler paused for compression three times during this fire and finally gave a blade exposed error message.The surgeon reported not noticing anything abnormal with the stapler instrument, reload, or tissue and did not expect any issues.The surgeon reported typically getting some pauses for compression when firing on this tissue but has never experienced a blade exposed error while firing on this tissue.The surgeon unclamped this sureform 60 and installed a new da vinci stapler and reload.The surgeon lined up this stapler with the incomplete previous staple line and fired to complete the line.No further issues were experienced during this procedure.The surgeon reported that there were no patient complications, but she was concerned about a potential future leak due to this event.A leak test was performed after this procedure and the results were negative.The patient was reportedly in good health with no post-operative complications.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sureform reload associated with the reported event and failure analysis found the reload knife to be exposed within the knife track.The cartridge below the blade did not exhibit any physical damage.The staple pushers were not damaged.The cover was removed and the blade was inspected and no damage to the blade was observed.The reload was found to exhibit damage on the distal and proximal ends measuring approximately 0.064" x 0.192" in length with material removed.The cartridge damage was found to be unrelated to the blade exposure.

• 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: 17038551
• Report Number: 2955842-2023-15365
• Device Sequence Number: 6516315
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)L90210517
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48360T-08
• Device Catalogue Number: 48360T
• Device Lot Number: L90210517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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
• Patient Sex: Female