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 07/05/2018

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 states not cutting well." (b)(4).

Manufacturer Narrative

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 is was manufactured at least 19 years ago.Service & repair confirmed the complaint condition on this unit.It was not operating correctly.This unit was manufactured with the original main board under the wallach name.At that time, the board manufacturer was rontron.This board is now obsolete and no longer used in production.A rontron board is not serviceable nor is it feasible to have a current board (supplied by the current vendor, precision graphics) put into an old unit like this one.The unit was scrapped and not available to determine which component had started to affect the cutting function.A definitive root cause is not readily available but given the age of the device it is possible wear and tear played a role on the complaint condition.Correction and/or corrective action : the customer was informed the unit could not be serviced and any repairs would not be economically feasible when a new unit can be acquired/purchased.Attempts to follow up with the customer on whether they would like the unit returned 'as-is' were made with no response.As no response was received this unit was scrapped out.Preventative action activity : coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"customer states not cutting well.Reference repair order: (b)(4)".Ref.(b)(4).

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 8228787
• MDR Text Key: 132538300
• Report Number: 1216677-2018-00105
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/30/2022
• 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