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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRACE MANUFACTURING INC. BPS300 BIPOLAR GRASPER
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GRACE MANUFACTURING INC. BPS300 BIPOLAR GRASPER Back to Search Results
Model Number BPS300
Device Problems Material Integrity Problem (2978); Physical Property Issue (3008); Torn Material (3024)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Type  malfunction  
Event Description
A sliver of black coating was found in the patient while using the bipolar.The sliver was taken out.Surgeon continued to use the bipolar afterwards.After the bipolar was taken out, the grasper on the bipolar appeared to have a missing part of the coating (same shape as the sliver).Overall, the surgeon was happy with this unit.No complications to the patient.Customer does not stock this item.
 
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Brand Name
BPS300 BIPOLAR GRASPER
Type of Device
BIPOLAR GRASPER
Manufacturer (Section D)
GRACE MANUFACTURING INC.
614 sr 247
russellville AR 72802
Manufacturer (Section G)
GRACE MANUFACTURING INC.
614 sr 247
russellville AR 72802
Manufacturer Contact
brandy dixon
614 sr 247
russellville, AR 72802
4799685455
MDR Report Key7455973
MDR Text Key107084853
Report Number3002770040-2018-12347
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 04/24/2018
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 Expiration Date06/30/2018
Device Model NumberBPS300
Device Lot NumberGML-00145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/26/2018
Initial Date FDA Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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