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

Model Number 909075

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.

Event Description

Generator is not working.Order: 94557.Findings: unable to change front panel modes.Select any option and it moves back to blend.Bad front panel.E-complaint-(b)(4).Quantum2000 electrosurg 909075 e-complaint-(b)(4).

Event Description

Generator is not working.Order: 94557.Findings: unable to change front panel modes.Select any option and it moves back to blend.Bad front panel.E-complaint-(b)(4).1216677-2020-00197 quantum2000 electrosurg 909075 e-complaint-(b)(4).

Manufacturer Narrative

Investigation: x-review dhr: x-inspect returned samples.Analysis and findings: complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 2/1/07 under wo #204689 and shipped on 12/20/2016.Manufacturing record review: dhr 204689 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 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 94557, visual evaluation: visual examination of the complaint unit revealed physical damage to the front of the generator.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit's damage was a contributing factor in its functional failure.Root cause: the unit was impacted on the front where the mode selection buttons are located.The origin of the impact on the device was not determined to be related to its shipment to csi.The impact is considered to have occurred while in the customer's possession at some point in time.Root cause is being attributed to end user handling error.Correction and/or corrective action: the unit was not repaired per the customer's request to repair only if under a certain amount.As a repair was not feasible to due cost and the fact that this product is has been discontinued this unit was returned to the customer 'as-is'.They will process its disposition internally.No further corrective action is necessary.No further training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• 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: 10488150
• MDR Text Key: 209031598
• Report Number: 1216677-2020-00197
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other