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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM STAPLER 60

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INTUITIVE SURGICAL, INC SUREFORM STAPLER 60 Back to Search Results
Model Number 480460-08
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the cause of the customer reported event can be attributed to use error. The instrument was discarded by the site and is not available for evaluation. If additional information is received, a follow-up mdr will be submitted. The da vinci x/xi instrument & accessory catalog states: training instruments are not approved for human use. Training instruments can be readily identified by the red instrument housing. Red instrument icons persist on the monitors when a training instrument is loaded onto the system. No image or video clip for the reported event was submitted for review. This complaint is reportable due to the following conclusion: during a da vinci-assisted sleeve gastrectomy surgical procedure, the staff had accidentally used a brand new sureform 60 stapler training instrument on a patient. The surgeon fired the training sureform 60 stapler instrument 3 times during the procedure. As soon as the staff realized the issue, the training instrument was removed. The patient was administered prophylactic antibiotics after the surgery was completed. There were no reported post-operative complications.
 
Event Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the staff had accidentally used a brand new training sureform 60 stapler instrument. The surgeon fired the training stapler instrument 3 times using 2 green and 1 blue stapler reloads. Intuitive surgical, inc. (isi) followed up with the surgeon and obtained the following information: the user was not aware that the instrument was labeled as not for human use (nfhu). Once the issue was realized, the instrument was removed and discarded. The patient did not develop any post-operative symptoms of infections but was administered antibiotics (ancef) after the procedure as a prophylaxis.
 
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Brand NameSUREFORM
Type of DeviceSTAPLER 60
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 Key13876424
MDR Text Key293147427
Report Number2955842-2022-10739
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K173721
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number480460-08
Device Catalogue Number480460
Device Lot NumberL90190708 0158
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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