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

Model Number	48445G-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the reload involved with this complaint and completed the device evaluation.Failure analysis confirmed the reported issue.The reload was found to have cartridge damage at the reload fin at the proximal end.A broken piece measuring approximately 0.018" x 0.027" was not returned.The reload was not found to have any blade damage.The root cause of this failure is attributed to user.A senior failure analysis engineer performed in-house testing to replicate this event and the following was documented.The reload was visually inspected and confirmed that the proximal fin was broken and had a piece detached.The fin appeared to have been split open and walls deformed outwards.The knife did not appear damaged and all pushers were deployed, suggesting that the reload was fully fired.Log review indicated this firing was completed.Damage was able to be re-created on an in-house reload by closing the jaws before fully seating the reload into the channel, causing the fin to get partially crushed by the anvil.Once this initial damage occurred, the reload was then properly seated in the channel and the reload was fired.Firing was able to be completed.The fin did not generate a fragment during the firing, but upon removal of the in-house reload, the damage to the fin appeared similar to the returned reload.In-house testing suggests root cause of fin damage is user related, likely from improper reload installation.A review of the system logs for the procedure date of (b)(6) 2021 was performed and the following was observed.Multiple error 1164's were noticed in the logs indicating that no stapler reload was found in the stapler instrument.These errors were always directly followed by error 22020 indicating that the installed stapler 45 instrument failed to engage on the system arm.The stapler 45 instrument used during this event was reused in a subsequent procedure with 15 uses remaining.A senior failure analysis engineer reviewed the instrument logs for the stapler 45 instrument used during this event and the following information was provided: "logs show that pn 470298-14, lot t10200917-0068 fired 1 reload (green).Firing was completed per the logs.The 1164 errors are reload recognition errors, and the 22020 errors are engagement failures.Neither one is likely related to the damage on the reload.Damage to the reload fin is likely due to improper installation (ex: closing the jaws without properly seating the reload into the channel).".
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, that the surgeon clamped the stapler 45 instrument on tissue and fired the stapler without difficulty.Once the stapler was removed from the patient, it was noted that a small piece of the stapler reload was hanging and embedded in the tissue.The surgeon was able to cut the tissue out with the piece of the remaining staple load and removed it from the patient.Per the staff technician (st) that loaded the stapler, there were no issues placing the load and it snapped into place correctly.The piece that broke off was at the back of the load.The procedure was completed as planned with no reported injury.Intuitive surgical inc.(isi) contacted the site robotics coordinator and additional information was obtained about the event.The target tissue that was being stapled during this event was the dorsal vein complex.A small section of the target tissue was excised due to the stapler reload fragment being embedded in the tissue.The surgeon reported that this excision of tissue did not adversely affect the procedure.The surgeon reported that the reload fragment was embedded in the tissue and thought it was better to excise the tissue than leave the fragment in the patient.There was no reported troubleshooting of this issue prior to excising the tissue.The customer was not aware of any suturing or other intervention due to this excision of tissue.The customer reported that they normally would not excise this tissue as it was not attached to the specimen being removed from the patient.The surgical staff inspected the stapler prior to this event and did not observe any issues.The surgeon reported that they believe this issue was caused by the stapler reload fired during the event.The patient was not hospitalized due to this event and no post-operative complications were reported to have occurred.The patient was reportedly discharged home.There are no photos or videos of this event.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD
• 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: 16925188
• Report Number: 2955842-2022-16425
• Device Sequence Number: 20543349
• Product Code: GDW
• UDI-Device Identifier: 10886874112820
• UDI-Public: (01)10886874112820(10)M90210322
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: 48445G-04
• Device Catalogue Number: 48445G
• Device Lot Number: M90210322 187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic