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

Model Number 470530-08

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The curved-tip stapler 30 instrument has not been returned to intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned for analysis and/or if additional information is received.A review of the logs with the instrument information provided resulted in no additional information.In addition, a review of the site's complaint history identified no other complaints related to the curved-tip stapler 30 instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: the curved-tip stapler 30 instrument was unable to unclamp the instrument jaws.Although there was no report of patient injury, if this event were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that the curved-tip 30 stapler instrument had a "need for key" malfunction code.No further details were provided.Follow-up was attempted to gather more information, but the customer was not able to provide any additional details related to the event.

• Brand Name: ENDOWRIST
• Type of Device: CURVED-TIP STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11181348
• MDR Text Key: 239106330
• Report Number: 2955842-2021-10040
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112717
• UDI-Public: (01)00886874112717(10)T10190606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470530-08
• Device Catalogue Number: 470530
• Device Lot Number: T10190606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1