MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD WHITE

Model Number	48630W-04
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the white (b)(4) stapler reload involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.A follow-up mdr will be submitted once the product is evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the curved-tip 30 stapler 30 instrument had remnants of the staples that were getting stuck in the jaws of the instrument each time it was fired.The customer had to double check the stapler to make sure no staples were stuck before they were reloaded; otherwise, it would not let them reload it properly.The staples were still stuck after use of the instrument was completed.This was an issue when sending the instrument for reprocessing.No known impact or patient consequence was reported.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The curved-tip 30 stapler instrument and the stapler white reload were analyzed and found the following: for the reload, there was no reported complaint against this part.The reload was returned unfired.No damage was found.The reload was installed in an in-house instrument then placed on an in-house system.The reload was fired without issue.All the pushers were deployed, and the staples formed onto the test sheet.The blade was at the distal end and not exposed.For the stapler instrument, failure analysis investigations confirmed but did not replicate the customer reported complaint.Failure analysis found the primary failure of reload recognition failure to the blades to be related to the customer reported complaint.The stapler instrument was found to have multiple reload recognition failures based on a review of the logs.The logs show error 1164 with p1 = 80.The log event error states: "the dlu pins inside the stapler jaws crotch are shorted, or the pins on the stapler cartridge are shorted.This may be due to a staple stuck in the stapler jaws crotch or a bad stapler cartridge." the stapler instrument was inspected and found no stuck staples on the dlu pins.The stapler instrument was placed and driven on an in-house system with an in-house blue reload installed.The stapler instrument passed initialization.The in-house reload was recognized.The stapler instrument moved intuitively with full range of motion in all directions.The jaw opened and closed properly.The stapler instrument clamped, fired and unclamped without any issues.The complaint was confirmed by failure analysis.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD WHITE
• 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: 19093394
• Report Number: 2955842-2024-13335
• Device Sequence Number: 18032022
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)M90220306
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 48630W-04
• Device Catalogue Number: 48630W
• Device Lot Number: M90220306 0651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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: Unknown
• 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 Sex: Unknown