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

Model Number	900-152
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type: no sample returned, review dhr.Analysis and findings.Distribution history.The complaint product was purchased from geotec,inc , packaged by csi.Manufacturing record review dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc record-(b)(4) 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 showed similar reported complaint conditions, however, there were no other complaints for the reported lot number.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: root cause not applicable as the complaint condition was not confirmed.Finished goods inventory of the reported lot number has been depleted.Previous engineering testing attempting to duplicate the wire breaking was conducted in march 2019 and was unsuccessful in producing the failures when using recommended power settings.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.
Event or Problem Description
Products have broken wire.Incident occurred during use, with no patient injury but medical/procedural intervention performed.1216677-2021-00232 fischer cone biop ex lg 900-152 e-complaint-(b)(4).

• Brand Name: FISCHER CONE BIOP EX LG
• Common Device Name: FISCHER CONE BIOP EX LG
• 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: 19075037
• Report Number: 1216677-2021-00232
• Device Sequence Number: 6853908
• Product Code: HGI
• UDI-Device Identifier: 00888937003727
• UDI-Public: 888937003727
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 10/25/2022
• Device Model Number: 900-152
• Device Catalogue Number: 900-152
• Device Lot Number: 271084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown