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

Model Number 6-70-807

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Reference: e-complaint-(b)(4).

Event Description

Report submitted by ri- 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.Ref: e-complaint-(b)(4).

Manufacturer Narrative

Investigation: x-no sample returned.X-review dhr.Analysis and findings: distribution history: the complaint product was manufactured at csi on 11/02/2020.Manufacturing record review: dhr 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/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.Root cause could not be definitively determined at this time but likely root cause can be attributed to customer error.Correction and/or corrective action: none.Reason: no further training required at this time.Was the complaint confirmed? no, this complaint was addressed in the field, the technician performed the following: power supplies replaced.Coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Report submitted by ri- 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.Ref: (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
• MDR Report Key: 10283319
• MDR Text Key: 209177922
• Report Number: 1216677-2020-00146
• Device Sequence Number: 1
• Product Code: MQG
• Combination Product (y/n): N
• PMA/PMN Number: K160504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6-70-807
• Device Catalogue Number: 6-70-807
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other