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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2017
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. Ref: (b)(4). Update: investigation, review dhr, inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals no similar issues. A review of the dhr reveals no anomalies. Service & repair did not find anything out of order during a visual inspection of the board. No cold solders were apparent, no missing components, and no damage was noted. The unit passed hi-pot testing as well. The unit works fine. The complaint is not confirmed. The pad used and returned is not dual and not a cooper recommended pad. Error on the part of end user is likely. The doctor may have produced an alternative path to ground. This cold have occurred by leaning on a patient's skin. Correction and/or corrective action: the unit was converted into a demo unit. The customer received a new unit. 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
(b)(4). "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".
 
Manufacturer Narrative
Coopersurgical inc. Is currently investigating 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. (b)(4).
 
Event Description
(b)(4). "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".
 
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Brand NameLEEP PRECISION INTG. SYS.
Type of DeviceLEEP
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 Key6690738
MDR Text Key247160158
Report Number1216677-2017-00048
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 company representative,consum
Reporter Occupation Physician Assistant
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
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 Manufacturer07/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2017
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: 07/06/2017 Patient Sequence Number: 1
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