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

Model Number	48645B-04
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has not received the 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 additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the system log for system (b)(4) on the reported event date of (b)(6) 2021 was performed.Per logs, it was confirmed that a blue stapler 45 reload (pn 48645b-04/ lot # l90210510 0556) was used with a stapler 45 instrument (pn 470298-12/ lot # t10190225 0058.The blue stapler 45 reload is a single use accessory.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it was alleged that the staple line was incomplete as a result of a tissue being pushed with no claim or evidence of mishandling/misuse.Missing staples may contribute to an incomplete staple line.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 esophagectomy transthoracic - chest anastomosis surgical procedure, there was a blockage of the stapler 45 at the end of the cut during the second stapling.The cutting and stapling was completed correctly, as the partial stapling had covered the whole part of the tissue to be stapled (less than 45mm).The stapler 45 was removed without any problem.There was no bleeding and no patient or material damage.The blade of the blue refill pushed a bunch of staples already anchored in the tissue.The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 7-dec-2021 and obtained the following additional information: the customer did not provide any information as there were no serious issues or injuries.
Additional Manufacturer Narrative
Additional information can be found in the following fields: g3, g6, h2, h10.D15- a review of the dsp logs for the stapler 45 associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer.Dsp logs show that pn 470298-12, lot t10190225-0058 was installed 3 times and fired two reloads (both blue).The first blue reload firing by this instrument was completed per the logs.The reload with pn 48645b-04, lot l90210510-0556 was the second reload fired by the stapler instrument.Firing of this reload resulted in a firing failure at 98% completion.It is not possible to know the root cause based on logs alone, however, in the complaint, it is mentioned that ¿the blade of the blue reload pushed a bunch of staples already anchored in the tissue, following the first stapling.¿ this indicates the user fired across a previous staple line, which is a likely contributor to the firing failure.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 13085607
• Report Number: 2955842-2021-11815
• Device Sequence Number: 17623731
• Product Code: GDW
• UDI-Device Identifier: 10886874112875
• UDI-Public: (01)10886874112875(10)L90210510
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: L90210510 0556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 12/26/2021
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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