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

Model Number 909075

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition.Once, the investigation is complete, a follow up report wil be filed.Reference e-complaint: (b)(4).

Event Description

Per repair authorization form: description of problem: unit makes popping sound when using electrodes on tissue.Arching when using electrodes coag not working on occasion.(b)(4).

Manufacturer Narrative

Coopersurgical is currently investigating the complaint condition.Once, the investigation is complete, a follow up report wil be filed.Reference e-complaint-(b)(4).10/3/2017 update: investigation.Analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.This unit was manufactured in 2015.Service & repair found the unit's output was operating to specifications.The arcing was not repeated either.The complaint was not confirmed.Upon visual inspection the unit's outer top casing was significantly scratched exposing bare metal.All the rubber feet were also removed.The repair log notes suggest these may have been contributing factors to the arcing claimed on the complaint.Scratches and removal of the rubber feet indicate the unit was modified or handled incorrectly.The root cause is not definitively determined but it is likely the complaint condition was due to end user error.Correction and/or corrective action: the unit was repaired 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

Per repair authorization form: description of problem: unit makes popping sound when using electrodes on tissue.Arching when using electrodes coag not working on occasion.Repair order number: (b)(4).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: 6822041
• MDR Text Key: 83844482
• Report Number: 1216677-2017-00058
• 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
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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: 07/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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