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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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STRYKER ENDOSCOPY-SAN JOSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Lot Number 19128FG2
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional 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: it was reported that an adhesive-type of debris was noted to be on suction tubing of product after product was opened, before it was dispensed onto the sterile field.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be foreign material fell inside during packaging or manufacturing.
 
Event or Problem Description
It was reported that foreign materials were found inside the sterile package.
 
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Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9823453
Report Number0002936485-2020-00009
Device Sequence Number16307070
Product Code GEI
UDI-Device Identifier37613327061353
UDI-Public37613327061353
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/12/2020
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? No
Operator of Device No Information
Device Lot Number19128FG2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/16/2019
Initial Report FDA Received Date03/12/2020
Patient Sequence Number1
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