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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); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2019
Event Type  malfunction  
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
"per report (b)(6) 2019 - received a call from dr (b)(6) at (b)(6) in (b)(6).She attempted a leep but the unit was beeping but would not cut, so the procedure was not started and the patient was sent home." (b)(4).
 
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.Ref e-complaint-(b)(4).
 
Event Description
"per report (b)(6) 2019 - received a call from dr (b)(6) at kaiser in springfield va.She attempted a leep but the unit was beeping but would not cut, so the procedure was not started and the patient was sent home." reference e-complaint-(b)(4).
 
Event Description
"per report june 14th 2019 - received a call from dr (b)(6) at kaiser in (b)(6).She attempted a leep but the unit was beeping but would not cut, so the procedure was not started and the patient was sent home." reference: (b)(4).
 
Manufacturer Narrative
Ref: (b)(4).*investigation: x-no sample returned.X-review dhr.*analysis and findings: a review of the 2 yr complaint history reveals no similar issues.A review of the dhr reveals no anomalies.The unit was not returned for an evaluation by service & repair.However, a csi service representative had indicated all the issues described in the complaint were user related after contacting the cusotmer.The complaint description is consistent with this finding as it was clear the failure description provided by the customer lacked a specific failure representative of the device's function or lack of function.The description states the unit did not cut but the procedure was never started in the same sentence.The beeping description is vague and not indicative a failure.Beeping can be a normal part of operation if continuous and indicative of an issue if intermittent.The root cause is being attributed to end user error.This unit is on recall 1216677-05-24-2019-002-r for the potential to have an overloaded c21 due to excessive current above the capacitors' rating.This failure is specifically for loss of foot pedal function.A device can still produce an output using a hand piece.The correction applied to a unit is on the main display portion of the board by installing a diode on c21.Customers have been notified of the recall and provided with guidance on returning units for addressing the issue.*correction and/or corrective action: a csi service representative visited the customer to train the end user in the use of the device.Should the product be returned at a later date this complaint will be updated accordingly.This complaint will be entered into the coopersurgical continuous improvement plan (cip).The corrective action on the failed c21 component is addressed through the recall and capa 725.No applicable correction available to train to concerning the particular complaint.A training record is on file for the re-work on recall units.*was the complaint confirmed? no.
 
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Brand Name
LEEP PRECISION INTG. SYS.
Type of Device
LEEP PRECISION INTG. SYS.
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
MDR Report Key8790405
MDR Text Key151108082
Report Number1216677-2019-00199
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
PMA/PMN Number
K963348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberLP-10-120
Device Catalogue NumberLP-10-120
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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