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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION SPECTRUM WRAP, STERILIZATION

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CONMED CORPORATION SPECTRUM WRAP, STERILIZATION Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2020
Event Type  malfunction  
Event Description
During procedure, spectrum instrument tip broke off.
 
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Brand NameSPECTRUM
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502
MDR Report Key9763329
MDR Text Key181157960
Report Number9763329
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/21/2020
Event Location Hospital
Date Report to Manufacturer02/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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