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

Model Number	48630G-04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Firing Problem (4011)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Failure analysis of the green reload was completed and the following information was received: the reload was found to have the knife exposed within the knife track and a firing failure.Log review showed that this reload was fired partially.Common causes of the failure mode exposed blade are typically attributed to mishandling/misuse, for example firing across a staple line or other obstructions.Additional observation not reported was body cartridge damage appeared under microscopic inspection.Skive and abrasive marks were found on the reload.No material appeared to be missing.The root cause is attributed to mishandling/misuse.Additional observation not reported was pusher damage.One pusher appeared to be broken with a lodged staple wedged in the pusher slot.Material appeared to be missing approximately 0.04" x 0.02".The root cause is attributed to a component failure.Failure analysis of the endowrist curved tip stapler was completed and the following information was received: the stapler was found to have the primary failure of a firing failure.Additional observation found that was not reported was a broken pivot pin.The pivot pin appeared to be sheared, allowing the wrist to jut out further than normal with applied force when articulated.No material appeared to be missing.Any potential fragments would have been retained by the stapler sheath.Root cause is attributed to mishandling/misuse.The instrument was also found to have a bent yaw plate.The yaw plate web was bent outwards towards the cardan.Root cause is attributed to mishandling/misuse.The instrument was additionally found to have a frayed grip cable at the wrist.Root cause is attributed to a component failure.An advanced system log review was conducted by an isi failure analysis engineer (fae) and reported the following information: logs show that a curved tip stapler 30 was installed on the system and fired 1 green reload.On the only install of this instrument, there was 1 competed clamp, followed by a firing failure, which stopped at ~40% completion.Error code 22030 was present in the logs, with parameters indicating the firing torque was too high.There were no incomplete clamp attempts, or unclamp failures for this instrument, and no other errors in the logs pertaining to this instrument.Next, logs show another curved tip stapler 30 installed on the system and fired 1 green reload.On the only install of this instrument there was 1 competed clamp, followed by a firing failure, which stopped at ~21% completion.Again, error code 22030 is present in the logs, with parameters indicating the firing torque was too high.There were no incomplete clamp attempts, or unclamp failures for this instrument, and no other errors in the logs pertaining to this instrument.This event is being reported due to the following conclusion: it was reported that during a da vinci-assisted pulmonary lobectomy procedure, the curved-tip stapler 30 had a partial fire, and the blade went only halfway.A backup stapler instrument was used; however, the same issue was encountered.The staples were retrieved on the same procedure; however, it was unknown if all loose staples or fragments were retrieved.There was procedure delay of at least 30 minutes.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, the endowrist curved-tip stapler 30 had a partial fire, and the blade went only halfway.A backup endowrist curved-tip stapler 30 instrument was used; however, the same issue was encountered.The issue occurred on the same arm and there were no draping issues.The staples were retrieved on the same procedure; however, it was unknown if all loose staples or fragments were retrieved.There was a procedure delay of at least 30 minutes.The instruments were inspected prior to use and no issues were observed.A sureform 45 was used to complete the stapling and the case was completed robotically.The target tissue being stapled together was bronchus and there was no bleeding seen due to the stapling issues.There were no post-operative complications due to the event.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
Note: refer to medwatch mfr report number 2955842-2023-11488 for the submission of the second stapler reload.Additional failure analysis (fa) findings/ clarification was received on 04-apr-2023 with the following information: to further clarify fa findings for this instrument, the secondary findings of a broken pivot pin, bent yaw plate, and frayed grip cable could have potentially contributed to the firing failure reported by the site.The broken pivot pin could have enabled the pivot plate to contact the cardans at articulated angles.Based on the evident damage to the components at the wrist, its possible a large load broke the pivot pin allowing for contact with other components at the wrist, ultimately bending the plate towards the fire cardan.The bent pivot plate could have potentially caused interference with the fire cardan during the firing, contributing to the firing failure.
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: 16593219
• Report Number: 2955842-2023-11470
• Device Sequence Number: 14686780
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M11221004
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M11221004 0824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 58 KG