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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0250040112
Device Problems Insulation (473); Break (1069); Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2019
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 there was a possible breach in insulation due to alleged broken insulation which could result in adverse consequences due to arcing.

 
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Brand NamePKG. MONOPOLAR ELECTROSURGICAL PROBE, L-TIP, 33CM
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
hannah stalnaker
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key9385519
MDR Text Key175271328
Report Number0002936485-2019-00526
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberK934094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0250040112
Device LOT Number166666
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/22/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
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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