MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC N/A

Model Number	48345G-01
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm sureform 45 stapler instrument and reload for failure analysis investigation.The instrument and the reload were analyzed and the following investigations were obtained: sureform 45 reload: the reload was found to have lodged staples wedged in between the reload in between the knife track.Visual inspection confirms there are 4 lodged staples, which can prevent the blade from progressing through the full firing trajectory.There was also cartridge damage and blade damage to the knife observed.The reload was found to have cartridge damage.Four staples were found wedged in between the reload, causing it to jam.The staples were removed from in between the reload.The knife was inspected and found be damaged.The event caused partially or wholly by the user of the device including sample handling.The reload was returned with rma 302120890010 sureform45 stapler.The reload blade was found to have mechanical indentations.Damage was found to the blade.There was also cartridge damage observed.Sureform 45 stapler: 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.The green reload was recognized as green.The instrument moved intuitively with full range of motion in a directions.The grips opened and closed properly.Review of procedure logs were unable to be retrieved during this time.The instrument was fully functional.There was no problem detected.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8 mm sureform 45 stapler instrument was used for a surgical task and did not recognize the green reload.It recognized it as a black reload.Use of the instrument was discontinued, and it was replaced to the backup.The user completed the procedure using the same system.No known impact or patient consequence was reported.

• Brand Name: N/A
• Common Device Name: N/A
• 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: 21097659
• Report Number: 2955842-2025-00194
• Device Sequence Number: 15667720
• Product Code: NAY
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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: 48345G-01
• Device Catalogue Number: 48345G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American