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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.Isi has requested the endowrist curved-tip stapler 30 instrument and the white stapler 30 reload for failure analysis investigation but at this time, the devices have not been returned.If additional information is received, a follow-up mdr will be submitted.An isi failure analysis engineer (fae) conducted a stapler log review and found the following: the logs show that the endowrist curved-tip stapler 30 instrument (part #470530-08, lot #t10200109-0045) was installed once and fired one reload (white).The firing of this reload failed at 64% completion.The logs show the user unclamped following the partial fire and the unclamp was completed per the logs.The logs show error 22030, indicating a firing failure.The logs also show that the e-stop (emergency stop) button was pressed ~4 mins after the completed unclamp and that the system detected the use of the srk on this instrument.Partial fires do not prompt users to use the srk.The logs confirmed that the issue was a partial fire and not an unclamping failure.The customer provided images of the reported event.A review of the provided images was performed by a fae.The following additional information was provided: the images show a white stapler 30 reload in a partially fired state, with a blade exposed.The blade exposed position aligns closely to the log finding of a failure at 64% completion.This complaint is being reported due to the following conclusion: during a da vinci assisted pulmonary lobectomy procedure, the surgeon experienced a firing issue while firing a white stapler 30 instrument with an endowrist curved-tip stapler 30 instrument on the pa.The surgical staff was able to remove the stapler instrument using a srk.However, the case was converted to open surgery since the surgeon did not trust the integrity of the stapler.The surgeon used a handheld stapler to transect the partially fired staple line and re-stapled the pa.The cause of the customer reported failure mode is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the surgeon used an endowrist curved-tip stapler 30 instrument, clamped on the pulmonary artery (pa), fired, and then received an error message that the blade was exposed.The stapler instrument would not unclamp.An emergent release key had to be used to remove the stapler instrument.There was some minor bleeding.All the staples were released on the first fire but did not transcend through tissue.The surgeon elected to convert the procedure to open surgery because the surgical staff did not trust the integrity of the stapler.An intuitive surgical, inc.(isi) senior clinical sales representative (csr) was contacted by the surgeon when the incident occurred.The surgical staff was able to use the stapler release key (srk) to release the stapler instrument that had a firing failure on the pa.The surgical staff was able to remove the stapler instrument, and it was reported there was some minor bleeding from the pa.The surgeon estimated the blood loss to be about 25-50ml for the case.There were some formed staples; however, the tissue was not transected.There were some malformed staples and buttress material was not used.The surgeon used a handheld stapler to transect the partially stapled line and re-stapled the pa after converting to an open surgical procedure.There is no video recording of the procedure.The patient had an extended hospitalization secondary to the reported incident.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a adverse event, as previously reported.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 15219238
• Report Number: 2955842-2022-13421
• Device Sequence Number: 12198998
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)M90210913
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 48630W-04
• Device Catalogue Number: 48630W
• Device Lot Number: M90210913 0719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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