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

Model Number	470430-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted esophagectomy transthoracic chest anastomosis surgical procedure, the stapler 30 instrument reload was fired and the instrument jaws locked.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler 30 instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not replicate nor confirm the customer reported complaint.Fa found the primary finding of cannot verify external event to be related to the customer reported complaint.The stapler was tested in-house and the instrument initialized, clamped fired, and unclamped without any issues.The instrument was tested twice and unclamped both times with no issues.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.No errors appeared during in-house testing and the log review showed no failures.No damage was found.There was no problem detected.Intuitive surgical, inc.(isi) received the stapler 30 blue reload involved with this complaint and completed the device evaluation.The reload was as an incidental return along with the instrument involved in this complaint.There was no reported complaint against the reload itself.Upon visual inspection, the reload appeared to be used and fully fired without any issues.The reload was disassembled in-house for inspection and no damage was found.The root cause is attributed to non-device related factors.No image or video of the procedure was provided for review.A review of the instrument logs for the stapler 30 (part number 470430-06/lot number t10181120 0034) associated with this event has been performed.Per the review, the stapler 30 was last used in a procedure on (b)(6) 2022 on system sk1665.The alleged instrument had 27 uses remaining after the last procedural use.This complaint is considered as a reportable malfunction event due to the following conclusion: it is unknown if the stapler 30 failed to unclamp/release from tissue.Medical intervention may be required in the event that the stapler fails to unclamp from tissue when commanded by the user or system.At this time, it is unknown what caused the unclamping 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.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30
• 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: 14825134
• Report Number: 2955842-2022-12467
• Device Sequence Number: 4689832
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700(10)T10181120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: 470430-06
• Device Catalogue Number: 470430
• Device Lot Number: T10181120 0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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 Age: 64 YR
• Patient Sex: Male