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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. BALL ELECTRODES BOX OF 5

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COOPERSURGICAL, INC. BALL ELECTRODES BOX OF 5 Back to Search Results
Model Number B0512
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
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: e-complaint-(b)(4). Analysis and findings: the reported event cannot be verified as the affected sample was not available at the time of this investigation. If the affected sample is returned in the future the complaint may be reopened and addressed as needed. Although indeterminable, it may be that the reported event was the result or symptom of a faulty grounding pad, or incompatibility with another device or component that was used in conjunction with the csi ball electrodes. The ball electrode is an outlet for power being supplied through it and does not have ground circuitry, thus, it's not likely that the ball electrode is the root cause for the reported event. A review of the lot dhr did not reveal any abnormality. Correction and/or corrective action: root cause is indeterminable as the affected sample was not available at the time of this investigation. Reason: per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient. Was the complaint confirmed? no.
 
Event Description
E-complaint-(b)(4), also reference e-complaint-(b)(4) "dr. (b)(6) pressed the cut button on the hand piece and got shocked twice. ".
 
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. (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 NameBALL ELECTRODES BOX OF 5
Type of DeviceBALL ELECTRODES BOX OF 5
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 Key6692403
MDR Text Key256921071
Report Number1216677-2017-00050
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K905747
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 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2020
Device Model NumberB0512
Device Catalogue NumberB0512
Device Lot Number212175
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/07/2017 Patient Sequence Number: 1
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