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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 Problems Failure to Cut (2587); Failure to Fire (2610)
Patient Problem Internal Organ Perforation (1987)
Event Date 03/31/2020
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the causes of the customer reported failure mode and the patient¿s operative complication are unknown. Isi has requested for the sureform stapler 60 instrument to be returned for evaluation. Isi has also attempted to contact the site to gather additional information regarding the reported event. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. Review of the site's system logs is unable to be performed at this time as the procedure date is unconfirmed. No image or video of the reported event were provided for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a sureform stapler 60 instrument did not staple and/ or cut, and the patient sustained a perforation of the stomach lining. At this time, the cause of the stomach perforation is unclear and it is unknown what medical intervention, if any, was administered due to the operative complication. Follow-up was attempted, but the patient information was either unknown or unavailable. The expiration date is not applicable. The product is not implantable.
 
Event Description
It was reported that during an unspecified vinci-assisted surgical procedure, the surgical staff encountered an issue with a sureform 60 instrument. It was alleged that the stapler instrument did not staple and/ or cut. Per the initial reporter, there was a perforation of the stomach lining. The following information is unknown: what surgical task was being performed, whether additional medical/ surgical intervention was or will be administered as a result of this issue, the procedure outcome, and patient's current status.
 
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Brand NameSUREFORM
Type of DeviceSTAPLER 60
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 Key10016320
MDR Text Key196769012
Report Number2955842-2020-10441
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 foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number480460-08
Device Catalogue NumberN/A
Device Lot NumberL90191014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/30/2020 Patient Sequence Number: 1
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