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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOP EX SM
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COOPERSURGICAL, INC. FISCHER CONE BIOP EX SM Back to Search Results
Model Number 900-150
Device Problems Material Discolored (1170); Melted (1385); Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.Ref e-complaint-(b)(4).
 
Event Description
"there seemed to be a concentration of the current at the tip of the device where the wire is embedded in the blue insulated part.This area was blackened and "melted" after attempting to use the device.There were sparks to indicate current at the tip but the current didn't appear to flow along the wire and the wire therefore didn't cut.Ref e-complaint-(b)(4).
 
Event Description
"there seemed to be a concentration of the current at the tip of the device where the wire is embedded in the blue insulated part.This area was blackened and "melted" after attempting to use the device.There were sparks to indicate current at the tip but the current didn't appear to flow along the wire and the wire therefore didn't cut.Ref: (b)(4).
 
Manufacturer Narrative
Ref: (b)(4).Investigation : x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings : distribution history: the 15006-01 fisher cone assembly was purchased from geotec, inc.As an oem finished product, received at csi 3/29/18, issued to work order 238667 as csi part number 900-150 and completed 4/25/18.Manufacturing record review: the dhr for this unit was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc- mo031518-02 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history record not applicable to this product.Historical complaint review: a review of the product two-year history indicated did not reveal any trends related to the description of the reported event.The reported event will be monitored for possible future reported event trending.Product receipt: the sample was not returned at the time of this investigation, and no rma was given.Visual evaluation: evaluation of the (b)(4) could not be completed as the complaint (b)(4) has not been returned to coopersurgical.If the (b)(4) should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the (b)(4)could not be completed as the complaint (b)(4) has not been returned to coopersurgical.If the (b)(4) should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: definitive root cause is indeterminable however, previous testing performed in 2011 in trying to replicate reported events of the wire "burning" or "snapping" indicated the product performed as intended, the testing was repeated in march of 2019 and resulted in the same manner.See attached copies of testing reports.Correction and/or corrective action: coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time, as the complaint condition was not confirmed.See attached copies of testing reports.Was the complaint confirmed? no.Preventative action activity : coopersurgical will continue to monitor this complaint condition for any trends.
 
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Brand Name
FISCHER CONE BIOP EX SM
Type of Device
FISCHER CONE BIOP EX SM
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key9105812
MDR Text Key209183710
Report Number1216677-2019-00254
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
PMA/PMN Number
K061651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/09/2021
Device Model Number900-150
Device Catalogue Number900-150
Device Lot Number238667
Was Device Available for Evaluation? No
Date Manufacturer Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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