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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN. LEEP 1000 Back to Search Results
Model Number L1000
Device Problem Failure to Cut (2587)
Patient Problem No Information (3190)
Event Date 02/27/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. The device involved in the complaint was returned by the customer and evaluated. Once the investigation is complete a follow-up report will be filed. Ref. E-complaint-(b)(4). Update: investigation: inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals similar issues. A review of the dhr is not available but not expected to provide relevant information for this complaint. This unit was manufactured in july 2007. Service & repair did not confirm the complaint. Unit operated to specifications. A definitive root cause for this complaint condition is not determined. However, it is likely the unit was not operated correctly suggesting an end user error. Correction and/or corrective action : the unit was found to operate to specifications and returned to the customer. This complaint will be entered into the coopersurgical continuous improvement plan (cip). 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? no.
 
Event Description
Review of service and repair log. Ref log number (b)(4). "stopped cutting during procedure". Ref: e-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. The device involved in the complaint was returned by the customer and evaluated. Once the investigation is complete a follow-up report will be filed. (b)(4).
 
Event Description
Review of service and repair log. (b)(4). "stopped cutting during procedure". (b)(4).
 
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Brand NameLEEP SYSTEM 1000 ESU GEN.
Type of DeviceLEEP 1000
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate dr
trumbull, CT 06611
2036015200
MDR Report Key6458276
MDR Text Key256921163
Report Number1216677-2017-00013
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL1000
Device Catalogue NumberL1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2007
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: 04/04/2017 Patient Sequence Number: 1
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