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

Model Number	48630G-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, the customer reported that the endowrist stapler 30 green reload failed to cut.The customer used a new reload to continue with the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the safety control specialist and obtained the following additional information: there was no fragment falling inside the patient¿s anatomy.The patient has not returned to the hospital for any post-surgical complications.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting that the stapler 30 green reload failed to cut, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endowrist stapler 30 green reload was analyzed and found to have the knife exposed within the knife track.The reload appeared to have been fully fired, but the knife is observed to be partially sticking out at the distal end of the reload.No logs are available for review at this time as no information about the stapler that was used was provided.Additional observations, which were not reported by site and related to the customer reported complaint were identified.The reload was disassembled in-house for inspection.The reload was found to have a broken knife.The broken piece, measuring approximately 0.031" x 0.058" in size, was not returned with the reload.Metal shavings were observed along the knife track when the reload was disassembled.The root cause of this failure was typically attributed to mishandling or misuse.The reload was found to have a damaged blade.The blade exhibited mechanical indentations.The root cause of this failure was typically attributed to mishandling or misuse.The reload was found to have cartridge damage at the distal end.No material appears to be missing.The root cause of this failure was typically attributed to mishandling or misuse.Additional analysis will be performed on the reload by an advanced failure analysis engineer.The complaint regarding cut failure was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is considered a reportable event due to the following conclusion: failure analysis found that the reload damage could result in a fragment fall inside the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling into the patient may require surgical intervention.
Additional Manufacturer Narrative
Additional analysis was performed on the stapler 30 green reload by an advanced failure analysis engineer.Reload was returned with back of the knife lug exposed at the distal end of the reload.Shuttle appeared to have fully progressed the length of the reload.Reload was disassembled and visual inspection of the internal components shows damage to the leadscrew proximal to the final shuttle position.Metal shavings from the leadscrew are visible within the cartridge.Additionally, the shuttle was observed to be bent at the pin relief slots, where the knife pins sit.Shuttle was bent outwards and away from the nominal position, which is in line with the leadscrew.Two metal components were observed to be lodged ahead of the shuttle.The components were later identified to be the posterior knife pin that had become dislodged, as well as the retaining metal that holds the pin in place with the knife.The pieces appear to have been met with a large force, causing the pin and retaining piece of the knife to break and subsequently get caught, as the leadscrew continued to rotate through the firing.The leadscrew was manually rotated, but the shuttle could not move distally.The knife was found exposed at the distal end, due to the break of the pin and retaining piece of the knife allowing it to separate from the shuttle assembly.It is likely that the broken pin and retaining pin stopped the forward progress of the knife, but the overall firing process was allowed to continue to completion.This reload was transferred to manufacturing and design engineering teams for evaluation.Based on their investigation, evidence does not point to a manufacturing issue with the reload.No additional findings.Common causes for the damage seen to the reload are firing over an obstruction or crossing an existing staple line.The reload was disassembled for further investigation.The missing pieces were found lodged in front of the shuttle.A large portion of the retaining ring of the knife and the missing knife pin were found.All additional missing pieces would be retained by the cover like the leadscrew threads.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GREEN
• 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: 16850688
• Report Number: 2955842-2023-12314
• Device Sequence Number: 7529358
• Product Code: NAY
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M90220206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M90220206 0699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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: 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 Sex: Unknown