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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Model Number 530.710
Device Problem Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the battery oscillator device had an unspecified malfunction.During an in-house engineering evaluation, it was determined that the device had intermittent operation, corrosion/rusting/pitting and foreign substance/debris/cleaning.It was further determined that the device failed pre-test for general condition, check function of the device, unintended motion and check the oscillation frequency with the meter.The device was not used in surgery and there was no patient involvement.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.Udi: (b)(6).
 
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Brand Name
BATTERY OSCILLATOR II FOR BPL II
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
3035526892
MDR Report Key14434043
MDR Text Key292052646
Report Number8030965-2022-03295
Device Sequence Number1
Product Code GEY
UDI-Device Identifier10886982240132
UDI-Public10886982240132
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 Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2022
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 Health Professional
Device Model Number530.710
Device Catalogue Number530.710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2022
Initial Date Manufacturer Received 05/11/2022
Initial Date FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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