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

Model Number 909075

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition.Once the investigation is complete, a followup report will be filed.(b)(4).

Event Description

Unable to cauterize during procedure.(b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition.Once the investigation is complete, a followup report will be filed.Reference e-complaint-(b)(4).Update 1/2/2018: investigation: analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.The complaint was not confirmed.Service & repair did not duplicate the complaint.The failure description was vague but conveyed the unit was not functioning.The unit functioned to specifications with no defects detected.The root cause for this complaint condition is being attributed to end user error.It is possible the hand piece used by the customer may been over used.The hand pieces are disposable accessory units that are to be replaced.Corrective actions.Correction and/or corrective action : the unit was evaluated under warranty.No defects were noted, hence there was not need to repair the unit.This unit was returned and the customer was notified to use new hand pieces.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.Was the complaint confirmed? no.

Event Description

Unable to cauterize during procedure.Reference e-complaint-(b)(4).

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate dr; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 7025814
• MDR Text Key: 93079071
• Report Number: 1216677-2017-00070
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 909075
• Device Catalogue Number: 909075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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): Required Intervention