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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOP EX MED
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COOPERSURGICAL, INC. FISCHER CONE BIOP EX MED Back to Search Results
Model Number 900-151
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/12/2019
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.(b)(4).
 
Event Description
Per mw5091773 received - report stated " patient consented for a laparoscopic tubal litigation, removal of iud and leep of the cervix, during the leep, the tips of the electrode came off the electrode to the patient uterus.A hysterectomy was done to locate the tip of the electrode and it was retrieved.Please see attached mw5091773 for details.Update -01.29.2020 - initiated follow-up reviewed extra step to complete procedure was hysteroscopy not hysterectomy as reported on mw5091773 (b)(4).
 
Manufacturer Narrative
*investigation.X-initiated manufacturer's investigation.X-no sample returned.X-review dhr.*analysis and findings.Ref (b)(4).Distribution history the 15006-02 fisher cone assembly was purchased from geotec, inc.As an oem finished product, issued to work order 219147 as csi part number 900-151 and completed 5/7/2018.Manufacturing record review dhr-900-151 - 238680 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review iqc- 18-05-01-004 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record.Service history not applicable for this product.Historical complaint review.A review of the 2-year complaint history did show similar reported complaint conditions.Product receipt.The complaint product has not been returned to coopersurgical.Visual evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product 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 complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product 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.*correction and/or corrective action corrective action: no further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.
 
Event Description
Per mw5091773 received - report stated " patient consented for a laparoscopic tubal litigation, removal of iud and leep of the cervix, during the leep, the tips of the electrode came off the electrode to the patient uterus.A hysterectomy was done to locate the tip of the electrode and it was retrieved.Please see attached mw5091773 for details.Update -01.29.2020 - initiated follow-up reviewed extra step to complete procedure was hysteroscopy.Not hysterectomy as reported on mw5091773.Ref (b)(4).
 
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Brand Name
FISCHER CONE BIOP EX MED
Type of Device
FISCHER CONE BIOP EX MED
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct CT 06611
MDR Report Key9687490
MDR Text Key182457196
Report Number1216677-2020-00002
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 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/07/2021
Device Model Number900-151
Device Catalogue Number900-151
Device Lot Number238680
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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