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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS. Back to Search Results
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).
 
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Brand NameLEEP PRECISION INTG. SYS.
Type of DeviceLEEP 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 Key6131918
MDR Text Key61313256
Report Number1216677-2016-00076
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
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 Received11/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-10-120
Device Catalogue NumberLP-10-120
Device Lot NumberN/.A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/26/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/29/2016 Patient Sequence Number: 1
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