MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHERCONE BIOPSY EXCISOR

Model Number 900-150

Device Problems Thermal Decomposition of Device (1071); Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not yet been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

"fischer cone bx arced and burned at the end during procedure no patient injury had to use another bx excisor to complete procedure" (b)(4).

Manufacturer Narrative

(b)(4).Investigation: x-initiated manufacturer's investigation, no sample returned, review dhr, x-inspect returned samples, inspect stock product.Analysis and findings: the event was confirmed in the visual evaluation of the returned sample, see the attached image.Definitive root cause of the reported event is indeterminable; however, several factors may be identified as being related to the evidenced result.The first is that the device may have been used outside its recommended operating power range, another may be the device was used in dense or diseased tissue and another size may have been more appropriate for the procedure being performed and yet another, may be that the generator that was used may have been in need of servicing.Previous engineering testing at csi failed in trying to duplicate reported failures when the device was used according to ifu instruction for use.Corrective actions: correction and/or corrective action: corrective action is not applicable at this time as the root cause is indeterminable.This type of event will continue to be monitored for evaluation and feasibility of any action taken in the future.Corrective action level 3, train personnel, x-none.Reason: per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient.Was the complaint confirmed? yes.Review and closure capa required? x-recommended continuous improvement program (cip) complaint closure letter required? ncmr issued? other regulatory action needed: preventative action activity reviewed.Trend and monitor to cip.

Event Description

"fischer cone bx arced and burned at the end during procedure.No patient injury.Had to use another bx excisor to complete procedure".(b)(4).

• Brand Name: FISCHERCONE BIOPSY EXCISOR
• Type of Device: FISCHERCONE BIOPSY EXCISOR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5705798
• MDR Text Key: 48058240
• Report Number: 1216677-2016-00044
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: 900-150
• Device Catalogue Number: 900-150
• Device Lot Number: 139647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2013
• 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