MAUDE Adverse Event Report: COOPERSURGICAL, INC. N20 SPHERICAL PROBE

Model Number	139
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported condition.
Event or Problem Description
Customer stated "eval".Repair tech stated "found - low defrost flow - replaced filter".(b)(4).N20 spherical probe 139 (b)(4).
Additional Manufacturer Narrative
Investigation: inspect returned samples.Distribution history: this complaint unit was manufactured at csi on 02/22/2002 under wo (b)(4).And shipped on 03/20/2002.Manufacturing record review: a review of the device history 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 quality release specifications.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: this unit was returned once in 2004 and once in 2007 for checks.Unit was returned in 2017 for mild corrosion on the latch spring and repaired.Historical complaint review: a review of the 2-year complaint history showed one 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 had a clogged up filter.Root cause: this complaint condition is being attributed to wear and tear.A clogged filter on a 19 year old unit is considered normal and the reason a filter is needed.Corrective actions.The unit was repaired 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 "eval".The repair technician reported: "found - low defrost flow".1216677-2021-00092-1 139 n20 spherical probe (b)(4).

• Brand Name: N20 SPHERICAL PROBE
• Common Device Name: N20 SPHERICAL PROBE
• 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: 11797485
• Report Number: 1216677-2021-00092
• Device Sequence Number: 11031115
• Product Code: HQA
• UDI-Device Identifier: 00888937004168
• UDI-Public: 888937004168
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/26/2023

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: 139
• Device Catalogue Number: 139
• 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: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 01/26/2023
• 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