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

Model Number 900-150

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.

Event Description

Patient undergoing procedure (biopsy) piece of wire from excisor noted to be missing.Ref e-complaint: (b)(4).

Event Description

Patient undergoing procedure (biopsy) piece of wire from excisor noted to be missing.Ref e-complaint (b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-review dhr x-inspect returned samples 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 (b)(4) as csi part number 900-150 and completed 8/8/2019.Manufacturing record review: the dhr for this unit was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc- mo072219-02 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 similar reported events.The reported event will be monitored for possible future reported event trending.Product receipt: the sample was received 4/13/2020.Visual evaluation: evaluation of the complaint (b)(4) was completed and the reported event was confirmed as reported, however, evidence that the wire had been intact was noted.It should be noted that each individual device is handled and visually verified during the manufacturing pouching process.Functional evaluation: evaluation of the complaint (b)(4) is not applicable to the event as reported and confirmed.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.Coopersurgical will continue to trend this complaint condition.No further corrective action is required at this time, as the complaint condition was not confirmed.No further training required at this time.Was the complaint confirmed? yes.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• 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
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 9805984
• MDR Text Key: 191310003
• Report Number: 1216677-2020-00077
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900-150
• Device Catalogue Number: 900-150
• Device Lot Number: 264290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other