MAUDE Adverse Event Report: COOPERSURGICAL, INC. RI WITNESS,SIT ON TOP,

Model Number 6-70-807

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Report submitted by ri on behalf of care fertility (b)(4)- per fcif "a couple of the embryologists have mentioned to me today that they get a small electric shock from the metal strip at the base of the ri witness plates, if they rest their arm at the edge of the plate.This seems to be affecting the left side of the icsi hood and the right side of the freezing hood." the unit is plugged directly to the lab wall socket.(not via any other equipment) an engineer has been prepped by the design team to visit and fault find.(b)(4).

Manufacturer Narrative

Investigation: distribution history: the complaint product was manufactured at csi on 11/feb/2020.Manufacturing record review: device history record was reviewed, and no non-conformities related to the complaint condition were noted.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 not 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.

Event Description

Report submitted on behalf of care fertility manchester."a couple of the embryologists have mentioned to me today that they get a small electric shock from the metal strip at the base of the ri witness plates, if they rest their arm at the edge of the plate.This seems to be affecting the left side of the icsi hood and the right side of the freezing hood." the unit is plugged directly to the lab wall socket.(not via any other equipment) an engineer has been prepped by the design team to visit and fault find.Ref:(b)(4).Ri witness sit on top 6-70-807-(b)(4).

• Brand Name: RI WITNESS,SIT ON TOP,
• Type of Device: RI WITNESS,SIT ON TOP,
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 75 corprate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 10516341
• MDR Text Key: 209221274
• Report Number: 1216677-2020-00204
• Device Sequence Number: 1
• Product Code: MQG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6-70-807
• Device Catalogue Number: 6-70-807
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2020
• 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