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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the customer reported failure mode and intra-operative complication cannot be determined.Isi has requested the stapler 30 white reload to be returned for failure analysis evaluation, but the product has not been received as of the date of this report.A follow-up mdr will be submitted if additional information is obtained.A system log review was performed for this procedure: no relevant errors were observed during this procedure.The stapler logs for this event were reviewed by an isi failure analysis engineer (fae): per the fae, the logs show curved-tip stapler 30 instrument (part #470530-08, lot #t10210104-0042) was installed 6 times and fired 4 reloads (all white).All firings were completed per the logs.There were no incomplete clamps by this instrument.The logs show an e-stop press occurred roughly 1 hour after the 4th firing, and the system detected use of the stapler release kit (srk) on this instrument.It is not clear what prompted the user to use the srk.This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, it was alleged that staples were not deployed when a white stapler 30 reload was fired with a curved-tip stapler 30 instrument.As a result, the patient lost 4,200 ml of blood and the procedure was converted to open surgery to control the bleeding.The cause of the customer reported failure mode and intra-operative complication is unknown.
Event or Problem Description
Intuitive surgical inc.(isi) received fda voluntary report with mdr report #mw5110971 stating: ¿pt scheduled for robotic-assisted left upper lobectomy.Emergently converted to open procedure due to bleeding.It appeared that all of the staples didn¿t deploy and the blade was still exposed, causing vascular injury and exsanguination of 4200ml of blood 30mm stapler used ref#(b)(4), lot # t102101040042 with load model #48630w, lot m90210503.Fda safety report id# (b)(4).¿ intuitive surgical, inc.(isi) has attempted to obtain additional information.However, as of the date of this report, no further details have been received.

• 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: 15307278
• Report Number: 2955842-2022-13735
• Device Sequence Number: 6484621
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(10)M90210503
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: M90210503 641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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