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

Model Number	48345W-02
Medical Device Problem Codes	Failure to Form Staple (2579); Firing Problem (4011)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical inc.(isi) received two white sureform 45 reload associated with this complaint.Failure analysis did not confirm the reported event.One stapler reload was returned and attached to a stapler instrument.The stapler reload was found to be used and fired.There was no damage to the stapler reload.The other returned stapler reload was also found to be used and fired.A visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.There was no damage to the reload or its components.No product issue was identified.Isi received the sureform 45 curved-tip stapler instrument associated with this complaint.Failure analysis did not confirm the reported event.A visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests, and moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues while using two white 45 reloads.The cut-line appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.Review of logs were unable to verify any failures.The instrument was fully functional.There was no problem detected.Additionally, the instrument was found to have the snake wrist cover torn.There was a chunk of the wrist cover that was torn and a piece was found to be missing.The missing piece was not returned with the instrument.Visual inspection displayed no signs of missing fragments.A rreview of the logs for the sureform 45 stapler instrument associated with this event has been performed.The logs show sureform 45 stapler instrument (part #480545-04; lot #k13240509-0364) was installed on the system 2 times and fired 2 white stapler reloads.On each install the first clamp was successful.On install 1, the firing was completed with 1 pause for compression, and on install 2 the firing was completed with no pauses for compression.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted donor nephrectomy procedure, an incomplete staple line occurred while stapling across the renal artery of the left kidney with a white sureform 45 reload installed on a sureform 45 curved-tip stapler instrument.Prior to applying the stapler, the surgeon fully skeletonized the renal artery.There was no calcification within the artery.The sureform 45 curved-tip stapler instrument clamped on the renal artery with no errors or issues.The firing process started and while halfway complete, the firing paused for compression and an unspecified message was produced.The firing stopped for approximately 5 seconds, then continued to completion.When the stapler instrument was unclamped, bleeding was immediately identified from the midline of the staple line.The stapler instrument was removed and it was identified that the midline of the staple line was only partially sealed.A hem-o-lok clip applier was used to apply a clip in order to successfully control the bleeding on the staple line.No further intervention was required.The procedure was completed robotically.The patient is recovering well with no postoperative complications.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD WHITE
• 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: 20036217
• Report Number: 2955842-2024-18383
• Device Sequence Number: 6507943
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(10)K10240417
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: 48345W-02
• Device Catalogue Number: 48345W
• Device Lot Number: K10240417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian