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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION AUTOTOME¿ RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545190
Device Problems Device Inoperable (1663); Material Twisted/Bent (2981); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
Event Type  Malfunction  
Event Description

The autotome became twisted at the tip when dr. (b)(6) was putting the tome through the cap so it was not functional after it twisted upon itself.

 
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Brand NameAUTOTOME¿ RX 39
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7634051
MDR Text Key112218224
Report Number7634051
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM00545190
Device Catalogue NumberM00545190
Device LOT Number21923591
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2018
Event Location Hospital
Date Report TO Manufacturer06/25/2018
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? No
Type of Device Usage

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