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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250070443
Device Problems Insulation (473); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2018
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. (b)(4).

 
Event Description

It was reported that the insulation was compromised.

 
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: during procedure, it was noticed the hook and sheath had some thermal damage causing arching. The failure(s) identified in the investigation is consistent with the complaint record. The probable root causes for the melted sheath could be the electrocautery probe was not in contact with tissue; the electrocautery probe is activated while there is irrigation fluid in the sheath; or the tip is retracted into the sheath while the current is activated. The device manufacturer date is not known. Gtin: (b)(4).

 
Event Description

It was reported that the insulation was compromised.

 
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Brand NamePKG, STRYKERFLOW ELECTROCAUTERY PROBE, L TIP, 5MM
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
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
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key7304984
MDR Text Key101278871
Report Number0002936485-2018-00197
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0250070443
Device LOT Number16H5204
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/16/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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