MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number	48630G-04
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection surgical procedure, a misfire was noted while using a curved-tip stapler 30 instrument and a green reload.The surgeon fired again to resolve the issue.Some of the staples were not removed.The procedure was completed.On 11-may-2021 intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer was working on the bowel (stapling intestine) when the issue occurred and it was the second reload use of the procedure.Report of stapler misfire and loose staples.No additional intervention was needed.No blood loss or patient injury was noted.Buttress material was not used and there were no malformed staples.The instrument/accessory was inspected prior to use and no damage or abnormalities were noted.The surgeon was using the green reload to achieve anastomosis.The stapler instrument was in use the entire case.There was no clamping issue noted.No further information is available.
Additional Manufacturer Narrative
The product has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A system log review was performed for the procedure of record and the following was observed: the logs indicate that there was a single firing failure logged during the procedure with the curved-tip stapler 30 instrument.A review of instrument log was performed and the instrument was last used on (b)(6) 2021, the date of the reported event, on system (b)(4).The curved-tip stapler 30 instrument was noted to have 13 uses remaining after this last use.No image or video clip was submitted for review.This complaint is being reported due to the following conclusion: it was alleged that the instrument misfired and staples fell inside the patient during a da vinci assisted procedure.It is unknown if staples were retrieved.At this time, it is unknown what caused the misfire 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 as unintended fragment(s) falling into the patient may require surgical intervention.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 RELOAD GREEN
• 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: 14796739
• Report Number: 2955842-2022-12372
• Device Sequence Number: 14714894
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)M91190826
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 48630G-04
• Device Catalogue Number: 48630G
• Device Lot Number: M91190826 0408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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