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

Model Number 909075

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/21/2017

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. (b)(4).

Event Description

(b)(4). Review of service and repair log # (b)(4). "unit sporadically turns on and off during procedures. " followed up with (b)(6) on 04/05/2017; she reported that the event occurred during the setup and during a procedure prior to entering the patient. They would turn on the machine and then it would flicker on and off. Sometimes it would not turn on at all and needed to restart.

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). Update 05/05/2017: investigation: x- 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. This unit was manufactured march 2009. Service & repair confirmed the complaint condition. The board was found to be damaged with loose components moving about freely. The root cause for this complaint condition is end user handling error as well as wear and tear. The unit was obviously damaged through some type of impact or impacts. Correction and/or corrective action: the customer requested the return of the unit as is and purchased a new unit. This complaint will be entered into the coopersurgical continuous improvement plan (cip).

Event Description

Reference e-complaint-(b)(4). Review of service and repair log # (b)(4). "unit sporadically turns on and off during procedures. " followed up with (b)(6) on (b)(6) 2017; she reported that the event occurred during the setup and during a procedure prior to entering the patient. They would turn on the machine and then it would flicker on and off. Sometimes it would not turn on at all and needed to restart.

• 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: 6460958
• MDR Text Key: 72193412
• Report Number: 1216677-2017-00018
• 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

• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 909075
• Device Catalogue Number: 909075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse