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

Model Number 6-70-807

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

"per e-mail report : ehp not reading tags in the corner of the heated glass.Work area keeps saying the dish has been removed.Latest version of rfid module and work area installed and problem persists.New ehp needed." (b)(4).

Event Description

"per e-mail report- : ehp not reading tags in the corner of the heated glass.Work area keeps saying the dish has been removed.Latest version of rfid module and work area installed and problem persists.New ehp needed." ref: (b)(4).

Manufacturer Narrative

Reference: (b)(4).*investigation: x-review dhr.X-inspect returned samples.*analysis and findings: two year history reviewed - shows no similar issues.Dhr reviewed, no issues reported.The product was returned for investigation and no problems were found (report attached), the complaint could not be replicated or confirmed.Should any additional information become available this complaint will be updated accordingly.Corrective actions: *correction and/or corrective action: this complaint condition is considered a level 4 corrective action per bsr-qar-026.Level 4 complaints will be reviewed and addressed in coopersurgical's continuous improvement program (cip).Service technician made aware of current practice.No re-training at this time.*was the complaint confirmed? no.*preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

• 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: 8798423
• MDR Text Key: 151435155
• Report Number: 1216677-2019-00203
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other