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

Model Number L1000

Device Problem Power Problem (3010)

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

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.

Event Description

Low power output.Poor cutting performance due to a low power output.Order: (b)(4).Ref: (b)(4).Lot/serial #: (b)(4).100 volt leep 1000 genera l1000j (b)(4).

Event Description

Low power output.Poor cutting performance due to a low power output.Order: (b)(4).Ref: (b)(4).Lot/serial #: (b)(6).1216677-2020-00180 100 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 in 2003 and shipped 3/31/2004.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: this unit was returned to csi and updated its diaphragm.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 94251.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit had a low output, but within calibration.Root cause: these units can go out of adjustment with use over time.A root cause has not been definitively determined, however, give the service time of this unit this issue is being attributed to wear and tear.Correction and/or corrective action : the unit's output values were adjusted to optimal range, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• 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: 10402227
• MDR Text Key: 223455579
• Report Number: 1216677-2020-00180
• 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
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2003
• 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