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	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).
Event or Problem Description
Report stated "defective/melted end of electrode".(b)(4).Fischer cone biop ex med 900-151.
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation, review dhr, inspect returned samples.Distribution history: the complaint product was purchased from geotec on 10/30/19.Manufacturing record review: dhr-900-151 - 271093 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc inspection report (11/4/2019) of top assembly part number 15006-02 for lots mo100719-01 and mo100719-02 from geo tec were 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 attached 2-year complaint history indicated similar reported complaint conditions.Product receipt: the complaint product returned to coopersurgical 5/27/2020.Visual evaluation: visual evaluation of the complaint unit was performed, and the reported event was confirmed as reported.Functional evaluation : not applicable for the state of the returned device.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.Corrective actions: coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time.No further training required at this time; complaint will be monitored for trending.Was the complaint confirmed? yes.
Event or Problem Description
Customer stated: "defective/melted end of electrode".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 ; 2036019870
• MDR Report Key: 10086498
• Report Number: 1216677-2020-00122
• Device Sequence Number: 3220856
• Product Code: HGI
• UDI-Device Identifier: 00888937003710
• UDI-Public: 888937003710
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Model Number: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 271093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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