MAUDE Adverse Event Report: COOPERSURGICAL, INC. N20 RETINAL PRB CURVED

Model Number 125

Device Problems Device Damaged Prior to Use (2284); Temperature Problem (3022)

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

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The reported condition is being investigated by coopersurgical, inc.A follow up report with investigation findings will be filed once available.Ref e-complaint-(b)(4).

Event Description

Report submitted by csi service & repairs -out-of box failure- cryo not making proper temperature.Details of incident: this new probe is not working properly.Dr.(b)(6) used it in surgery for the first time today.And it is not freezing to optimal temperature and when it finally does reach temperature (-80) it take like at least 50 seconds which is too long.Follow-up initiated for additional info on impact to patient.Follow-up response stated " patient is doing well.No adverse even related, additional medical attention may likely need to refreeze distichia.Patient was under general anesthesia longer than usual due to trouble shooting cryo machine and probe.May need to repeat procedure.Ref e-complaint-(b)(4).N20 retinal prb curved 125 e-complaint-(b)(4).

Manufacturer Narrative

Investigation : x-review dhr , x-inspect returned samples.Analysis and findings : complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 10/29/2018 under wo #(b)(4) and shipped on 6/9/2020.Manufacturing record review: dhr 252192 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: the product tested to specification as the device was found to meet all visual and functional test specifications.Root cause not applicable as the complaint condition was not confirmed.The problem description is consistent with incorrectly operating the console (ce-20000) at 400 psi, therefore this is attributable to end user error.As the complaint confirmed? no.Correction and/or corrective action the customer was provided with a new unit.The complaint unit was converted to a demo under wo #(b)(4).No further corrective action is necessary.Preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report submitted by csi service & repairs -out-of box failure- cryo not making proper temperature.Details of incident: this new probe is not working properly.Dr.Venturi used it in surgery for the first time today.And it is not freezing to optimal temperature and when it finally does reach temperature (-80) it take like at least 50 seconds which is too long.Follow-up initiated for additional info on impact to patient.Follow-up response stated " patient is doing well.No adverse even related, additional medical attention may likely need to refreeze distichia.Patient was under general anesthesia longer than usual due to trouble shooting cryo machine and probe.May need to repeat procedure.(b)(4).1216677-2020-00160 n20 retinal prb curved 125 (b)(4).

• Brand Name: N20 RETINAL PRB CURVED
• Type of Device: N20 RETINAL PRB CURVED
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10310079
• MDR Text Key: 209220798
• Report Number: 1216677-2020-00160
• Device Sequence Number: 1
• Product Code: HQA
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 125
• Device Catalogue Number: 125
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other