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

Model Number 900-151

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 07/19/2019

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.

Event Description

"dr.Claims that she set the valley lab generator at the proper setting and when she went to perform the leep the wire burned out " "dr.Claims that settings were set as ifu states".Ref e-complaint # (b)(4).

Manufacturer Narrative

Ref e-complaint: (b)(4).Investigation: x-initiated manufacturer's investigation: x-review dhr.X-inspect returned samples.Analysis and findings: distribution history: the complaint product was purchased from geo tech, packaged by csi on 10/31/2017 under work order: (b)(4).Manufacturing record review: dhr-900-154-232539 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 not applicable for this product.Historical complaint review: a review of the attached 2-year complaint history did show similar reported complaint conditions.Product receipt: the complaint product was received, verified, and confirmed for the reported event.Visual evaluation: visual examination of the complaint product was performed and reported complaint event was confirmed.Functional evaluation: functional evaluation is not applicable to this complaint.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.

Event Description

"dr.Claims that she set the valley lab generator at the proper setting and when she went to perform the leep the wire burned out "."dr.Claims that settings were set as ifu states".Ref e-complaint: (b)(4).

• 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 Key: 8863729
• MDR Text Key: 153649035
• Report Number: 1216677-2019-00217
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K061651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/30/2020
• Device Model Number: 900-151
• Device Catalogue Number: 900-151
• Device Lot Number: 232539
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other