MAUDE Adverse Event Report: COOPERSURGICAL, INC. N2O SPHERICAL PROBE

Model Number	139
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc is currently investigating the reported condition.
Event or Problem Description
Per customer: freezes while holding probe.Repair log: (b)(4).N20 spherical probe 139.E-complaint (b)(4).
Event or Problem Description
Customer stated: "freezes while holding probe".1216677-2021-00127-1, 139 n20 spherical probe, e-complaint- (b)(4).
Additional Manufacturer Narrative
Investigation: inspect returned samples.Distribution history: this complaint unit was manufactured at csi on 3/23/1998 under wo #1169 and shipped on 3/25/1998.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 has been serviced in 2017 for a torn silicone line/tube, 2018 for trapped moisture stuck inside, and in january 2021 for poor seating causing low flow and the filter was replaced.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 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.Corrective actions: the unit was evaluated, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No further training required.Was the complaint confirmed? no.

• Brand Name: N2O SPHERICAL PROBE
• Common Device Name: N2O 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: 11964574
• Report Number: 1216677-2021-00127
• Device Sequence Number: 4000813
• Product Code: HQA
• UDI-Device Identifier: 00888937004168
• UDI-Public: 888937004168
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 06/09/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown