MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN.; LEEP 1000

Model Number 52969

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint was returned by the customer and evaluated.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Review of service and repair log.Ref repair log no.(b)(4).Per repair auth form : "socket for active electrode needs to be replaced.Symptom: intermittent outputs "was there patient injury: no" (b)(4).

Manufacturer Narrative

(b)(4).Investigation: initiated manufacturer's investigation, no sample returned, review dhr, inspect returned samples, inspect stock product.*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 pertinent information for this complaint.This unit was manufactured in 2012.The complaint condition was confirmed.The socket on the front panel was very loose causing intermittent operation of the unit.A failure like this is infrequent.A root cause for this complaint condition is being attributed to handling error resulting in early wear and tear on the component.Corrective actions: *correction and/or corrective action, the unit was repaired and returned to the customer.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Corrective action level 4.Train personnel.None.Reason: no applicable correction available to train to at this time.Complaints will be continuously monitored to determine if there is any new trend for this complaint condition.*was the complaint confirmed? yes.Review and closure.Recommended continuous improvement program (cip) capa required? #: complaint closure letter required? ncmr issued? #: other regulatory action needed: *preventative action activity reviewed.Trend and monitor to cip.

Event Description

Review of service and repair log.Ref repair (b)(4).Per repair auth form : "socket for active electrode needs to be replaced.Symptom: intermittent outputs."was there patient injury: no".(b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP 1000
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6131914
• MDR Text Key: 61440538
• Report Number: 1216677-2016-00074
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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