MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG.

Model Number 909075

Device Problem Compatibility Problem (2960)

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

Event Date 08/08/2019

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.Ref e-complaint: (b)(4).

Event Description

Unit will no longer work with the foot pedal.Ref.E-e-complaint: (b)(4).

Event Description

Unit will no longer work with the foot pedal.Ref.E-e-complaint - (b)(4).

Manufacturer Narrative

Ref e-complaint - (b)(4).Investigation: no sample returned.X-review dhr: x-inspect returned samples.Distribution history: this complaint unit was manufactured at csi on 9/19/16 under wo # (b)(4) and shipped on 9/22/16.Manufacturing record review: dhr 210960 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the attached 2-year complaint history showed did show one similar reported complaint conditions.The front panel pc was repaired.Product receipt: the complaint unit was processed as a recall unit and received under rma #299730 on 8/30/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: the unit was confirmed to fall within the recall for failed foot pedal activation.Root cause : engineering identified one issue with a capacitor that had the potential to be overloaded due to excessive current above the capacitors' rating.The part of the circuit that had been found to have this issue was c21 located on the display board.It's failure affected the foot pedal function due to being shorted.The root cause for this complaint condition is being attributed to a board update from non-rohs to rohs boards.The change had made the c21 capacitor prone to excessive current.Correction and/or corrective action: the unit was fitted with a new board (wo # (b)(4) already updated to have the zener diode which was put in place to mitigate the c21 component from being overloaded with excessive current.Ecn-21881 was executed to update the print referencing supporting eng-test10487 & eng-test-10504.The remaining boards in stock were updated to include the diode under wo # (b)(4).Capa 725 was issued and a recall (1216677-05-24-2019-002-r) will address the remaining units from the implementation of the rohs board into production up to the addition of the zener diode.Was the complaint confirmed? yes.

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8931305
• MDR Text Key: 155635716
• Report Number: 1216677-2019-00235
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 909075
• Device Catalogue Number: 909075
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other