MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG.; QUANTUM 2000

Model Number 909075

Device Problem Sparking (2595)

Patient Problem No Code Available (3191)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint was returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Reference (b)(4).

Event Description

Reference (b)(4).Review of service and repair log # 85902."machine was set for cut 50 watt.Patient grounded before machine turned on.Md was not near the foot pedal- pen was down.Vacuum started running a spark hit patient's thigh.".

Manufacturer Narrative

Coopersurgical inc.Is currently investigation the reported complaint condition.The device involved in the complaint was returned by the customer and evaluated.Once the investigation is completed a follow up report will be filed.Reference e-complaint: (b)(4).Investigation: inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr is not available but not expected to provide relevant information for this complaint.Based on the s/n, this unit was manufactured before 2000.Service & repair was not able to duplicate the complaint condition.The unit was evaluated and tested but no failures were detected.Although this unit is over a decade old the check on the unit demonstrated a fully functional unit.There is no definitive root cause for this complaint condition.It is possible there was some end user error or certain conditions were present during the customer's observation(s).Correction and/or corrective action: the unit was evaluated at a charge and returned to the customer.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

Reference e-complaint: (b)(4).Review of service and repair log # 85902."machine was set for cut 50 watt.Patient grounded before machine turned on.Md was not near the foot pedal- pen was down.Vacuum started running a spark hit patient's thigh.".

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM 2000
• 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: 6663109
• MDR Text Key: 78459962
• Report Number: 1216677-2017-00047
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• 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: 05/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2017
• 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