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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND

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INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND Back to Search Results
Model Number 480422-01
Device Problem Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The vessel sealer extend instrument was discarded by the site and is not available for return to isi for evaluation. A review of the system and instrument logs has been performed. There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality. A review of the device logs for the vessel sealer extend (part# 480422-01 | lot/serial# (b)(4)) associated with this event has been performed. Per this review of the logs, the vessel sealer extend was used on (b)(6) 2020 via system serial# (b)(4) as initially reported. There were 0 uses remaining after this usage as the reported device is a single-use instrument. A review of the site's complaint history has been performed and no related complaints have been identified. At this time, no images or video recording of the procedure have been provided to isi for review. This complaint is being reported because the vessel sealer extend instrument reportedly did not sufficiently seal despite generating the "seal completed" tones. While there was no reported injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted nissen fundoplication surgical procedure, the vessel sealer extend instrument, which was being used with an e-100 generator) began to "stick¿ as the procedure progressed. It was noted that the vessel sealer extend instrument appeared to be especially sticky on fatty tissue. On smaller tissue bundles (small tissue fibers near the hiatus), the sticking after seal/transection would cause the seal to partially open and cause bleeding. Intuitive surgical, inc. (isi) followed-up with the initial reporter that was present for the reported procedure: no approximate blood loss was provided; however, a blood transfusion was not needed. The procedure was completed successfully with the da vinci surgical system and there was no injury or adverse outcome to the patient. The issue was resolved by resealing the tissue bundle with the vessel sealer extend instrument or another bipolar instrument. There was not a long continuous tone reported to have occurred when the energy pedal was pressed, but the fast audible tones did generate. There were no errors observed. There was no excessive tension on the target tissue. There was no vessel calcification and the jaws did not come into contact with a clip, suture, staple, or other metal object. The customer indicated that the instrument is not available for return. Patient demographic information is not available.
 
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Brand NameENDOWRIST
Type of DeviceVESSEL SEALER EXTEND
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 Key11024564
MDR Text Key241684148
Report Number2955842-2020-11362
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422-01
Device Catalogue Number480422
Device Lot NumberL92200721 0293
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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