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

Model Number	48645B-04
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the endowrist stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) did not replicate nor confirm the customer reported complaint that a staple was stuck to the jaw after the stapler fired.Upon visual and microscopic inspection, no damage was found at the wrist assembly.No lodged or stuck staple was observed in the grip housing of the stapler.The instrument was placed on a system and moved intuitively with full range of motion in all directions.The grips opened and closed properly and clamp and fire test passed on two separate trials.Staple formation on a test sheet was proper.Additional observations include that the instrument experienced clamping failures during the procedure on system sk2458 on (b)(6) 2022.The site attempted to re-adjust several times but could not successfully clamp and therefore a firing attempt was not performed.The instrument was placed on the system using new reloads.The fire and clamp functions were performed without issue at different wrist angles.Fa found a clamping failure in the logs during a sigmoid colectomy with a blue 45 reload.The instrument had 1 install and 1 install with repeated clamping failure.The clamp history included 10 incomplete clamps and 2 complete clamps for an incomplete clamp completion percentage of 76-93%.Most clamp hold times were around 17-25 seconds.Isi has not received the blue endowrist stapler 45 reload for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.The alleged event occurred on the 4th use of the instrument.A review of the system log for system sk2458 on the reported event date of (b)(6) 2022 was performed.Per logs, it was confirmed that a blue endowrist stapler 45 reload (pn 48645b-04/ lot # l90210315-0024) was used with an endowrist stapler 45 instrument (part# 470298-14 / lot# t10190711-0073) in a sigmoid colectomy procedure.The blue endowrist stapler 45 reload is a single use accessory.No image or video of the procedure was provided for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that a staple was stuck to the jaw after firing.However, the staple line was reportedly fine.If not recognized during the procedure, medical intervention, including additional surgical procedures, may be required in the event that the staples are not delivered from the reload.At this time, it is unknown what caused the event to occur.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.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the endowrist stapler 45 had a staple stuck to the jaw after it fired.The procedure was completed with no reported injury.On 20-jun-2022, intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer stated the instrument was inspected prior to use and no damage was noted.The task at the time was stapling.The customer explained there was a staple left stuck to the jaw after it was fired.The customer is returning the instrument to make sure it wasn¿t damaged as they did not want to use the stapler again if it was bent or damaged.The customer stated the stapler had previously worked.There were no errors/messages generated when the event occurred.The target tissue was bowel.The customer stated that the staple line looked fine, but the surgeon used another stapler to complete the procedure.The customer ensured there was no adverse effect to the tissue.The reload is not available for return and there is no video/images of the event/device.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45 RELOAD BLUE
• 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: 14973768
• Report Number: 2955842-2022-12905
• Device Sequence Number: 17402221
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90210315
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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: 48645B-04
• Device Catalogue Number: 48645B
• Device Lot Number: L90210315 0024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 07/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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 Sex: Unknown