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

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.(b)(4).

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 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.".

• Brand Name: BALL ELECTRODES BOX OF 5
• Type of Device: BALL 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 Key: 6692403
• MDR Text Key: 79527001
• Report Number: 1216677-2017-00050
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905747
• Number of Events Reported: 1
• 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 Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/27/2020
• Device Model Number: B0512
• Device Catalogue Number: B0512
• Device Lot Number: 212175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other