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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SERFAS ENERGY 90-S CRUISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER ENDOSCOPY-SAN JOSE SERFAS ENERGY 90-S CRUISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 0279401200
Device Problems Self-Activation or Keying (1557); Failure to Shut Off (2939)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that the device was continuously activating.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: likely functioning automatically as the probe button and the footswitch was not pressed.The probable root cause/s could be probe short (due to fluid ingress), button stuck on firing position.
 
Event Description
It was reported that the device was continuously activating.
 
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Brand Name
SERFAS ENERGY 90-S CRUISE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9338184
MDR Text Key174961360
Report Number0002936485-2019-00521
Device Sequence Number1
Product Code GEI
UDI-Device Identifier07613327057034
UDI-Public07613327057034
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0279401200
Device Catalogue Number0279401200
Device Lot Number19159AE2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2019
Date Manufacturer Received11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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