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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.710
Device Problem Leak/Splash (1354)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device leaked dark fluid in the patient.It was reported that an immediate intervention took place which was wound irrigation with saline and beta-dine mixture.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.It was not reported if there was prolonged hospitalization.The reporter stated that the status of the patient post-surgery was fine.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Correction: g1-2: manufacturing site name: the manufacturer location was incorrectly documented as waldenburg in the initial report.The location has been updated to oberdorf.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that a fluid leak was not noted during evaluation.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.However, it was determined that the device failed pretest for general condition and trigger test.It was further determined that the trigger became loose from the electric control unit (ecu), and the lock ring and guide sleeve were worn.It was determined that the moving parts did not move smoothly.The assignable root cause was determined to be due to component failure from normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H6: service history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a service history review was performed which indicated that the device was serviced over a year for a service condition that is not relevant to the current reported condition.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.
 
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Brand Name
BATTERY OSCILLATOR II FOR BPL II
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9918147
MDR Text Key195317089
Report Number8030965-2020-02089
Device Sequence Number1
Product Code GEY
UDI-Device Identifier07611819491847
UDI-Public07611819491847
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Initial Date Manufacturer Received 03/11/2020
Initial Date FDA Received04/02/2020
Supplement Dates Manufacturer Received04/30/2020
05/05/2020
05/14/2020
Supplement Dates FDA Received05/01/2020
05/06/2020
05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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