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

Model Number 909075

Device Problems Grounding Malfunction (1271); No Device Output (1435)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.(b)(4).

Event Description

Will not give out put with multiple handpieces.Does not give indication of ground connection.Order: (b)(4).(b)(4).

Manufacturer Narrative

*investigation x-inspect returned samples *analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 09/13/2011 under wo #107812 and shipped on 9/15/2011.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed 2 similar reported complaint conditions.One unit was damaged and the other was not confirmed.Product receipt: the complaint unit was returned on a repair.However, based on log 93743, this unit was at csi on 1/29/2020.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit had power but there was no output for cut, coag or blend modes.Root cause: the root cause of this issue has been attributed to wear and tear.The board in this unit was also confirmed to be of the older obsoleted version.*correction and/or corrective action the unit was returned to the customer 'as-is' as requested.A repair was not feasible and 909075 has been discontinued.Service & repair also directed the customer to the customer service to offer the latest version of csi's electrosurgical device/system, p/n lp-10-120.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Will not give out put with multiple handpieces.Does not give indication of ground connection.Order: 93743 ref.E-complaint (b)(4).

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct
• MDR Report Key: 9706524
• MDR Text Key: 183093589
• Report Number: 1216677-2020-00052
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K963653
• 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: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• 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: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other