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

Model Number	124
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported condition.
Event or Problem Description
Leaking handle gets ice cold.(b)(4) found; high frezze flow 16.5mm, poor seating.3.N20 retinal prb straight 124.E-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation: review dhr: inspect returned samples.Distribution history: this complaint unit was manufactured at csi on 11/14/2017 under wo # (b)(4) and shipped on 2/06/18.Manufacturing record review: dhr (b)(4) was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: this unit was returned for a torn outer tubing.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit required an adjustment.Root cause: no definitive root cause for this issue could be reliably determined at this time.Note: high freeze flows will affect the unit from reaching optimal temperature.This unit's spring house assembly required re-working indicating the ball setting was off.The ball is soldered onto the end of a wire (spring assembly) where both are exposed to the rushing gas and moved into the proper seating position in the exiting orifice.Corrective actions: the unit was repaired/adjusted, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training required at this time.Was the complaint confirmed? yes.
Event or Problem Description
Customer stated: "leaking handle gets ice cold".124 n20 retinal prb straight (b)(4).

• Brand Name: N20 RETINAL PRB STRAIGHT
• Common Device Name: N20 RETINAL PRB STRAIGHT
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 1151 enterprise dr; ste 100; coppell, TX 75019 ; 4752651665
• MDR Report Key: 11941167
• Report Number: 1216677-2021-00121
• Device Sequence Number: 3662395
• Product Code: HQA
• UDI-Device Identifier: 00888937004144
• UDI-Public: 888937004144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 124
• Device Catalogue Number: 124
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown