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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BUR, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0375704500
Device Problems Overheating of Device (1437); Excessive Heating (4030)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
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 the device got hot.
 
Event Description
It was reported that the device got hot.
 
Manufacturer Narrative
Alleged failure: cib mike, purchasing, gets very hot, po 9308cvln.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be (1) excessive force applied to the cutter/burr by the user with poor or no suction during use.Excessive force may cause friction due to bur shaft assembly and housing assembly interaction.(2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
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Brand Name
PACKAGING, FORMULA SHAVER (HAND CONTROL)
Type of Device
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key9461756
MDR Text Key176582018
Report Number0002936485-2019-00553
Device Sequence Number1
Product Code GFF
UDI-Device Identifier07613327057638
UDI-Public07613327057638
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0375704500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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