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

Model Number	48345B-01
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the cause of the intra-operative complication can be possibly traced to mishandling/misuse.Intuitive surgical, inc.(isi) has received the blue sureform 45 reload associated with this complaint and completed investigations.The reload was found to have the knife exposed within the knife track.Common causes of an exposed blade are typically attributed to mishandling/misuse.The stapler instrument involved with the firing failure was not returned.The blade was found to be lodged within the cartridge causing cartridge damage.No pieces were found to be missing.The reload blade was removed from the cartridge and inspected.The blade exhibited mechanical indentations.The root cause of the cartridge damage and blade damage is typically attributed to mishandling/misuse.A follow-up mdr will be submitted if additional information is obtained.An advanced instrument log review was performed for this procedure by an isi advanced failure analysis engineer (fae).Per the fae, the logs show a sureform 45 stapler instrument was installed on the system 4 times and failed to engage 1 time on the 3rd install attempt.The other 3 install attempts were successful and the user fired 3 blue reloads.On each of the 3 successful installs, there was one completed clamp, followed by a firing with no pauses for compression.There were no incomplete clamp attempts, incomplete unclamps, or firing failures for this instrument.There were no other stapler related errors in the logs.This complaint is being reported due to the following conclusion: during a da vinci-assisted distal gastrectomy procedure, there was a tissue push incident involving a blue reload during the third stapler fire.Bleeding from the cut surface was seen which required suturing.A third-party stapler was subsequently used to cut the target tissue.
Event or Problem Description
It was reported that during a da vinci-assisted distal gastrectomy procedure, an error occurred while using the sureform 45 stapler instrument with a blue sureform 45 reload.The issue occurred with the third stapler fire, during the gastric reconstruction when performing the closure of the common foramen of the stomach.It was observed that the tissue being clamped was coming up toward the distal end of the stapler.There was no tension but bunching of the tissue was observed during stapling.The stapler jaws did not involve the opening or releasing during the firing sequence.The stapling issue did not generate any error messages.The surgeon did not know whether he had fired over an existing staple line.Bleeding was observed from the closed common foramen area.The amount of bleeding was very small in quantity.No blood transfusion was administered.The surgeon performed additional suturing to control the bleeding.A third-party stapler was used to cut the target tissue subsequently.The instrument and reload had been inspected prior to use with no damage or abnormalities found.The procedure was completed robotically.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 16284873
• Report Number: 2955842-2023-10468
• Device Sequence Number: 11982210
• Product Code: GDW
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)T90220217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: 48345B-01
• Device Catalogue Number: 48345B
• Device Lot Number: T90220217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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