MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-14
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed but did not replicate the customer reported complaint.The instrument was found to have a firing failure based on log review.The instrument was found to have loose staples lodged in the jaws at the pins.The instrument was also found to have a reload recognition failures based on log review.The digital signature processor logs indicate the reload color was manually selected.The instrument was installed on an in-house system.The instrument passed initialization test.The instrument clamped and fired successfully.Isi also received the blue reload involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The reload was found to have the knife exposed within the knife track.The reload was found to have a firing failure.Log review showed that this reload was fired partially.The known common cause of this failure is likely attributed to mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted donor hepatectomy surgical procedure, the stapler 45 instrument experienced an error during staple firing - misfire and blade exposed message.The customer used a third-party handheld stapler to complete procedure, which was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during a right hepatectomy, the stapler misfired, giving an error message - "stapler misfire, blade may be exposed".The stapler achieved 100% clamp allowing the surgeon to fire the stapler, but when cutting the tissue, the stapler did not complete the cut and triggered an error, leaving the blade exposed.As the hepatectomy was being done for hepatocellular carcinoma, wide margins were being done to allow for complete excision of the tumor, so the stapler was cutting through normal liver tissue.The patient had y90 radioembolization of 2 hepatomas, but the issue occurred when the surgeon was cutting through normal liver tissue.The surgeon did not encounter any obstructions such as clips, staples, bone, or other hard objects between the instruments jaws.The stapler had been fired multiple times prior to misfiring without issue.The surgeon experienced clamping issue only once prior to misfire issue, then he took a smaller piece of tissue which resolved the clamping issue.The surgeon used a third-party stapler to complete the staple line and no medical intervention was required.Surgeon preferred to finish case laparoscopically through hand assist port already in place although there was no indication that the system was in a down state.The customer also noted that upon further inspection, it looked like a staple may have been caught in the pins in the bottom of where the reload is placed.The customer was unable to remove this staple.The stapler was rinsed and wiped in between unloading and reloading each staple firing, but it seems this wasn't seen until after the case.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 17067488
• Report Number: 2955842-2023-15804
• Device Sequence Number: 17814727
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10190522
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10190522 0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 103 KG