MAUDE Adverse Event Report: COOPERSURGICAL, INC. N20 CATARACT PRB STRT

Model Number	126
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported condition.
Event or Problem Description
E-complaint: (b)(4).Customer stated "leak".Repair tech stated "leak le found, mfg june 1984, boiler tip is sharp, no leaks found - filed tip smooth & polished".Follow-up with repair tech "the boiler tip touches the eye, sharp risks injury to the patients eye, they are silver so they deform if pinched or dropped this one looked dropped" repair order 95785 n20 cataract prb strt 126 e-complaint: (b)(4).
Event or Problem Description
Customer stated: "leak".1216677-2021-00051-1 126 n20 cataract prb strt (b)(4).
Additional Manufacturer Narrative
Investigation inspect returned samples distribution history: this complaint unit was manufactured at csi in 1984.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.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 on a repair.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found to function properly.Root cause: although the unit functioned the end/tip was damaged as if dropped on the floor.The root cause for this complaint condition is being attributed to end user handling error.Corrective actions the unit was repaired, 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? no.

• Brand Name: N20 CATARACT PRB STRT
• Common Device Name: N20 CATARACT PRB STRT
• 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 ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11569989
• Report Number: 1216677-2021-00051
• Device Sequence Number: 3546398
• Product Code: HQA
• UDI-Device Identifier: 00888937004212
• UDI-Public: 888937004212
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• 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: 126
• Device Catalogue Number: 126
• 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: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/25/2021
• 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