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

Model Number 909075

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 09/17/2019

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.

Event Description

Customer stated "physician was shocked twice.Patient was not shocked." ref.E-complaint (b)(4).

Event Description

Customer stated "physician was shocked twice.Patient was not shocked" ref.E-complaint-(b)(4).

Manufacturer Narrative

E-complaint-(b)(4).Investigation: x-inspect returned samples.Analysis and findings: distribution history: this complaint unit was manufactured at csi in 1997.Manufacturing record review: a review of the device history record could not be performed at the time of this investigation.However, it should be noted each lot is thoroughly reviewed to ensure that products released meet all coopersurgical specifications.Should the device history record be located this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: this unit was returned for low output on all modes and captured on log 51583 in 2009.An outside vendor had been used to adjust the board output properly.Historical complaint review: a review of the attached 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on log 92978, this unit was at csi on 9/19/19.Visual evaluation: visual examination of the complaint unit revealed damage to the chassis with scratches leaving the bare metal substrate exposed.Internally, the components on the front display board were burnt with burn marks on the inner side of the front chassis.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Due to the damage further functional checks were not needed.The damage was significant enough to question the customer if they would authorize a repair.Root cause: the root cause of this issue has been attributed to wear and tear.The unit was in the field for 22 years with only one return for an adjustment to the outputs.The correspondence also confirms scratches which explains the shocks felt by the end user.The scratches are likely due to physically inserting the generator into the integration set up.Note: this unit is using the original rontron board.Correction and/or corrective action: the customer elected to have the unit scrapped out.As an original rontron board was in use on this unit, it would not have been serviceable anymore.The customer elected to purchase a new unit.Coopersurgical will continue to monitor this complaint condition for any trends.No further training required at this time.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: QUANTUM2000 ELECTROSURG.
• Type of Device: QUANTUM2000 ELECTROSURG.
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9272931
• MDR Text Key: 190547327
• Report Number: 1216677-2019-00288
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other