MAUDE Adverse Event Report: COOPERSURGICAL, INC. EHP RFID MODULE

Model Number 5-70-801

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

Event Description

Ehp/workstation electrical shock."after putting eggs for xxxxx into the icsi dish i got an electric shock from the ri reader which made me knock the dish.(b)(4).Ehp rfid module 5-70-801.E-complaint- (b)(4).

Event Description

Ehp/workstation electrical shock."after putting eggs for xxxxx into the icsi dish i got an electric shock from the ri reader which made me knock the dish.Cas-06099-v9y9r2 1216677-2021-00086 ehp rfid module 5-70-801 (b)(4).

Manufacturer Narrative

Investigation analysis and findings (b)(4).Was the complaint confirmed? yes."distribution history: it could not be determined when the complaint product was manufactured because the lot/serial number of the completed unit was not provided.Manufacturing record review: a review of the device history record could not be performed because the lot/serial number of the completed unit was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did show similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical as this is a field service complaint.Visual evaluation: this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Functional evaluation: this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Root cause: this is a field service complaint, there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Likely root cause can be attributed to modern low voltage electronic equipment which is most commonly powered by switching power supplies (psus) (e.G.Laptop/tablet power supplies, usb chargers, etc).These are often ungrounded types, which means that there is no direct connection to earth.Protection against electric shock is provided by means of isolation between the mains input and the low voltage output, instead of by using an earth connection.As there is no direct connection to earth, a charge can build up on the output of the power supply.Depending on the design of the power supply, this can be to a sufficient level to cause a tingling sensation, or a similar sensation to a static electricity shock when initially touching a conductive part of the device (or a connected device).Corrective action: the action is to change the tablet power supply and usb hub to an alternative type (surface pro docking station).Subsequent measurements, using the surface pro docking station, indicate that the level of charge is low enough not to be felt by the user.Coopersurgical will continue to monitor this complaint condition for any trends.Reason: no further training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: EHP RFID MODULE
• Type of Device: EHP RFID MODULE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11761876
• MDR Text Key: 261661669
• Report Number: 1216677-2021-00086
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5-70-801
• Device Catalogue Number: 5-70-801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other