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

Model Number 909075

Device Problem Failure to Cut (2587)

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Customer stated "not cutting like it should." reference repair order: 90830.(b)(4).

Manufacturer Narrative

Ref: (b)(4).Investigation : x-inspect returned samples.Analysis and findings: a review of the 2 yr complaint history reveals similar issues.This unit was manufactured before 2000.Service & repair confirmed there was no output to the hand piece.This unit is an older version of the quantum units which had used a main board that is now outdated and not supported.This unit is not repairable and a new main board cannot be used to replace the old version.Further evaluation on this unit is not available.Given the age of the unit, an original wallach quantum, the root cause for this complaint condition is being attributed to wear and tear.Correction and/or corrective action: the customer was informed this unit cannot be repaired and only the leep precision electrosurgical device is available should they desire to purchase a new unit.The customer opted to have the old unit returned to them 'as-is'.This complaint will be entered into the coopersurgical continuous improvement plan (cip).No applicable training to train to.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Customer stated "not cutting like it should." reference repair order: 90830 ref: (b)(4).

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8662789
• MDR Text Key: 147027234
• Report Number: 1216677-2019-00161
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• 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
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other