MAUDE Adverse Event Report: COOPERSURGICAL, INC. 100 VOLT LEEP 1000 GENERA

Model Number L1000

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Ref: (b)(4).Customer stated "when power is turned on, the er2 error appears on lcd screen and the device becomes inoperable".Repair tech stated "verified - replaced diaphragm, switch, and pcb mount".Reference repair order #(b)(4).Volt leep 1000 genera l1000j (b)(4).

Manufacturer Narrative

Investigation x-inspect returned samples analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 11/21/2012 under wo # (b)(4) and shipped on 1/13/2015.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.However, based on log (b)(4).Visual evaluation: visual examination of the complaint unit revealed physical damage to the mounts and the on/off switch.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit's damage resulted in the "er2" message on the display.Root cause: the complaint condition is being attributed to end user handling error.Diaphragm update: the diaphragm was changed out due to a previous finding where the material degraded to the point where it no longer functioned as intended and prevents activation of a unit.This unit's diaphragm was in working order.However, the corrective action for this issue requires returned units be updated to the new material and applicable on this unit.Correction and/or corrective action: the unit was repaired, updated, tested to specification, and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Corrective actions relevant to the updated diaphragm are as follows; coopersurgical service and repair replaced the diaphragm on the unit, tested it and returned it to the customer.Engineering has successfully tested a replacement material made of silicone for use in repairs going forward, eng-test-10341-r.The ifu was also updated to add a safety check via ecn-20444.A service bulletin was issued to existing customers informing them to check for this issue and return the unit if needed.All product in fg and sk, as applicable, were reworked to replace the previous versions of the dfus on all applicable products.The repaired unit will have been repaired with this new silicone material.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Ref: e-complaint-(b)(4).Customer stated "when power is turned on, the er2 error appears on lcd screen and the device becomes inoperable" repair tech stated "verified - replaced diaphragm, switch, and pcb mount".Reference repair order # (b)(4).1216677-2021-00010 100 volt leep 1000 genera l1000j e-complaint-(b)(4).

• Brand Name: 100 VOLT LEEP 1000 GENERA
• Type of Device: 100 VOLT LEEP 1000 GENERA
• 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: 11236716
• MDR Text Key: 234424780
• Report Number: 1216677-2021-00010
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• 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