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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 Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2016
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. Investigation underway.
 
Event Description
Intermittent foot pedal function (suspect panel socket or main pcb). Display went blank during use. Handpiece activation does function. No patient injury reported on (b)(6) 2016. (b)(4).
 
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. Follow up (b)(6) 2016, 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 years complaint history reveals similar issue. A review of the dhr reveals no anomalies. The complaint unit, leep precision intg. Sys. , p/n-lp-10-120 and serial#(b)(4), was received with intermittent coag output; the foot pedal and hand piece activation both fail. Repair tech had confirmed that pc board was bad inside. The complaint was confirmed after evaluation. The unit was built in august of 2016 and it was 100% inspected prior to release. The replacement unit was sent back to the customer (replacement order#(b)(4)). After pcb replacement the complaint unit was restocked as demo. There is no definitive root cause available for this complaint condition. The potential root cause could be related to bad components. Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. Correction and/or corrective action": the complaint unit was returned back to stock as demo. The customer had received a replacement unit. This complaint will be entered into the cooper surgical continuous improvement plan (cip).
 
Event Description
Intermittent foot pedal function ( suspect panel socket or main pcb). Display went blank during use. Handpiece activation does function. No patient injury reported on (b)(6) 2016. Reference (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 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key6169464
MDR Text Key62676042
Report Number1216677-2016-00087
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2016
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: 12/13/2016 Patient Sequence Number: 1
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