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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., RESECTOR SHAVER BLADE, F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

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STRYKER ENDOSCOPY-SAN JOSE PKG., RESECTOR SHAVER BLADE, F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Catalog Number 0375542000
Device Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2019
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 foreign material was found in sterile packaging.
 
Manufacturer Narrative
Alleged failure: reported that there was red paint within the teeth of the burr the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be it is possible that a small amount of plastic ¿red flash¿ was created during the inductive weld process and was not removed.The inner cutter accidentally scraped the housing hub during insertion and remained attached to the cutter teeth.Improper cleaning process, qc incoming, and in-process inspections.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
Event Description
It was reported that foreign material was found in sterile packaging.
 
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Brand Name
PKG., RESECTOR SHAVER BLADE, F - SERIES - 4.0MM
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key8976354
MDR Text Key156964493
Report Number0002936485-2019-00376
Device Sequence Number1
Product Code GFA
UDI-Device Identifier37613327061810
UDI-Public37613327061810
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/29/2020
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? Yes
Device Operator Other
Device Catalogue Number0375542000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2019
Initial Date Manufacturer Received 08/13/2019
Initial Date FDA Received09/09/2019
Supplement Dates Manufacturer Received08/13/2019
Supplement Dates FDA Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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