MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

Model Number LP-10-120

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

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

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical is investigating the complaint condition reported.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

""this unit was ordered in may but just put into service.It was here for a repair in (b)(6) ( log (b)(4) ) for a major repair but it just failed during start up before surgery.The unit would not cut with either handpiece." (b)(4).

Manufacturer Narrative

(b)(4).Investigation: initiated manufacturer's investigation.No sample returned.X- review dhr.X- 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 reveals no anomalies.This unit was in for a repair in september which resulted in a board replacement.Reference log 83516.The complaint was confirmed not functional.The unit was not further evaluated as it had returned twice, deemed not worth a reworking and subsequently scrapped.The root cause for this complaint condition is not available with the device gone.The failure for a device to fail at the same location twice like this is not common.Corrective actions: correction and/or corrective action: the customer received a new unit.This returned lp-20-120 was scrapped out.This complaint will be entered into the coopersurgical continuous improvement plan (cip).Corrective action level 4.Train personnel.X-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.X- 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

"this unit was ordered in may but just put into service.It was here for a repair in sept ( log 83516 ) for a major repair but it just failed during start up before surgery.The unit would not cut with either handpiece." (b)(4).

• Brand Name: LEEP PRECISION INTG. SYS.
• Type of Device: LEEP PRECISION INTG. SYS.
• 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 cprporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6131918
• MDR Text Key: 61313256
• Report Number: 1216677-2016-00076
• 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: Physician
• 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: LP-10-120
• Device Catalogue Number: LP-10-120
• Device Lot Number: N/.A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2016
• 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