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

Model Number	48360T-08
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection (lar) procedure, the surgeon encountered a ¿tissue too thick¿ message while attempting to fire a green sureform stapler 60 reload with a sureform stapler 60 instrument.The surgeon reportedly had the same result after attempting to fire two black sureform stapler 60 reloads.For an unclear reason, the surgeon was unable to reconstruct the anastomosis.As a result, a rectal amputation was performed.The case was reportedly converted to open surgery.On 07-sep-2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: while the surgeon was attempting to fire a green sureform 60 reload, a "tissue too thick" message was generated by the system.As a result, it was alleged that a partial fire occurred, the staple line was incomplete, and the rectum could not be dissected.The surgeon mentioned that he observed free staples at the end of the staple line; however, he could not recall finding any malformed staples.The targeted tissue was not damaged.After the first firing attempt with the green sureform 60 reload, the surgeon attempted to fire two black sureform stapler 60 reloads.The surgeon claimed that although a black stapler reload was introduced, the display highlighted a green stapler reload instead.Furthermore, the surgeon claimed that changing to black stapler reload on the display was not possible.The system was ready to fire and did not show any errors.While attempting to fire the two black sureform stapler 60 reloads, the surgeon alleged that he encountered the ¿tissue too thick¿ messages again.As a result, the surgeon decided to use a hand-held ¿echelon flex 60 device¿ (a non-isi stapler instrument).The surgeon noted that ¿no anatomical reconstruction with anastomosis could be performed¿ and as result, rectal amputation was performed.The surgeon explained that ¿placing another, deeper staple line was impossible due to the distancy [sic] of the dissection just above the sphincter apparatus.¿ the procedure was not converted to open surgery; however, according to the surgeon, perineal dissections was performed as usual practice.The surgeon stated that the procedure outcome was "uneventful." due to the stapling issues, the surgical procedure was delayed by around 100 minutes.The total operative time was 278 minutes.The patient has not experienced any post-operative complications and has been discharged.No video of the procedure are available for review.The instruments involved with this event will not be return to isi for evaluation.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received a black sureform stapler 60 reload associated with this complaint and completed the device evaluation.Failure analysis (fa) repliacted/confirmed the customer reported complaint that a partial fired occurred.The stapler reload was found to have the knife exposed within the knife track.The stapler reload was partially fired based on in-house testing.No cartridge damage was found.The reload was disassembled in-house for inspection.No damage to the knife was observed.No image or procedure video was provided for review.A review of the system logs for the event date of 20-aug-2020 has been performed by an isi post market surveillance specialist and the following was observed: there is no clear evidence that a black sureform stapler 60 reload was used during two da vinci-assisted lar procedures performed by surgeon that day.Therefore, there is no clear evidence that a black sureform stapler 60 reload was involved with the reported event as reported by the surgeon.This complaint is being reported due to the following conlcusion: during a da vinci-assisted low anterior resection (lar) procedure, the surgeon encountered a ¿tissue too thick¿ message while attempting to fire a green sureform stapler 60 reload with a sureform stapler 60 instrument.The surgeon reportedly had the same result after attempting to fire two black sureform stapler 60 reloads.For an unclear reason, the surgeon was unable to reconstruct the anastomosis.As a result, a rectal amputation was performed.The case was reportedly converted to open surgery.

• 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: 14825708
• Report Number: 2955842-2022-12478
• Device Sequence Number: 20036984
• Product Code: GDW
• UDI-Device Identifier: 10886874113858
• UDI-Public: (01)10886874113858(10)L90190729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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: 48360T
• Device Lot Number: L90190729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 45 KG