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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF CASING FOR 14.4V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES OBERDORF CASING FOR 14.4V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.132VET
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was returned for evaluation. The device was evaluated and the reported condition was not confirmed. An assessment was performed and the device met all manufacture's specifications. Therefore, an assignable root cause was not determined. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
(b)(4). The actual device has been returned and is currently pending evaluation. Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported that during an unspecified veterinary surgical procedure, it was observed that the battery casing on the battery device would quit intermittently. It was reported that there was a ten to fifteen minute delay in the procedure due to the event, and an unspecified spare device was available for use. The procedure was completed successfully. There was no human patient involvement as this was a veterinary procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameCASING FOR 14.4V BATTERY
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6735252
MDR Text Key161312263
Report Number8030965-2017-13745
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.132VET
Device Lot Number11988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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