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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFIRE 2 CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFIRE 2 CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 0475100000
Device Problems Electrical Shorting (2926); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2023
Event Type  malfunction  
Event Description
It was reported that there was a thermal event.
 
Manufacturer Narrative
Alleged failure: error/froze after rebotting.The failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board possibly due to fluid ingress.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
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Brand Name
PKG, CROSSFIRE 2 CONSOLE
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18250677
MDR Text Key329517657
Report Number0002936485-2023-01217
Device Sequence Number1
Product Code GEI
UDI-Device Identifier07613327058109
UDI-Public07613327058109
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071859
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0475100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2023
Initial Date Manufacturer Received 11/07/2023
Initial Date FDA Received12/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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