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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 Device Displays Incorrect Message (2591)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once the investigation is complete a follow up report will be filed. Reference e-complaint-(b)(4). Update: 1/5/2018. Investigation. Analysis and findings: a review of the 2 yr complaint history reveals one similar issue. A review of the dhr reveals the use of variances on the build. The variances were for the use up of non-rohs boards on the integration unit and for the proper fast-on crimps to use in the assembly. Neither indicates a correlation to the failure described on 1 of the 14 units built under wo #224637. The complaint was not confirmed by service & repair and operated to specifications. The root cause for this complaint condition is not reliably determined but potentially due to end user error. The customer may had incorrectly operated the unit or incorrectly set up the device for use. Correction and/or corrective action: the unit was confirmed to operate to specifications. Although the unit functioned and the complaint could not be duplicated it was not re-stocked and scrapped out. The customer received a new unit. The customer was asked for follow up questions by sustaining engineering but no significant information was garnered. The customer confirmed the replacement unit was being used in the same manner with no issues. 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
"this customer used their leep precision system for the first time and every time that dr. Ritchie tried to blend or coag the system had the "rf leakage" error and would not function. The cut function worked fine. The doctor had to use silver nitrate on the patient to stop the bleeding. This order was placed 8/11 and again this was the first case for this leep system. The patient was not adversely affected due to the malfunction. " reference e-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once the investigation is complete a follow up report will be filed. (b)(4).
 
Event Description
"this customer used their leep precision system for the first time and every time that dr. (b)(6) tried to blend or coag the system had the "rf leakage" error and would not function. The cut function worked fine. The doctor had to use silver nitrate on the patient to stop the bleeding. This order was placed (b)(6) and again this was the first case for this leep system. The patient was not adversely affected due to the malfunction. " (b)(4).
 
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Brand NameLEEP PRECISION INTG. SYS.
Type of DeviceLEEP PRECISION INTG. SYS.
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 Key6991393
MDR Text Key256922063
Report Number1216677-2017-00068
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 health professional,user faci
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
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 Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
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