MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOP EX MED

Model Number	900-151
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Ref (b)(4).
Event or Problem Description
Details surrounding event- during excision biopsy, wire broke and charred (blue) insulation on excisor.Surgeon reports a total of three incidents where wire has broken during procedure.This is first reported incident.Ref (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation: no sample returned.Review dhr.Distribution history the 15006-02 fisher cone assembly was purchased from geotec, inc.As an oem finished product and issued to work order(b)(4) as csi part number 900-151 and completed 4/23/2019.Manufacturing record review: the dhr for this unit was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: a review of the incoming inspection record could not be performed as the record could not be located at the time of this investigation.If the incoming inspection record should be located going forward, it will be reviewed, and this complaint amended accordingly.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 revealed similar reported complaint conditions.Product receipt: the complaint unit was not returned to coopersurgical.Visual evaluation: evaluation of the complaint unit could not be completed at the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appending to this investigation.Functional evaluation: evaluation of the complaint unit could not be completed at the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appending 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.Corrective actions: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? no.
Event or Problem Description
Customer stated: "during excision biopsy, wire broke and charred (blue) insulation on excisor".1216677-2020-00055-1 900-151 fischer cone biop ex med (b)(4).

• Brand Name: FISCHER CONE BIOP EX MED
• Common Device Name: FISCHER CONE BIOP EX MED
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 9734374
• Report Number: 1216677-2020-00055
• Device Sequence Number: 764692
• Product Code: HGI
• UDI-Device Identifier: 00888937003710
• UDI-Public: 888937003710
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 264280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown