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

Model Number	139
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported condition is being investigated by coopersurgical, inc.
Event or Problem Description
Order: 94632.Found;silicon torn.High freeze flow.15mm should be 10mm.Ref e-complaint-(b)(4).N20 spherical probe 139 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation.Review dhr: inspect returned samples.Distribution history: this complaint unit was manufactured in 1997.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.The complaint does not specify a complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed physical damage.The silicone tubing was torn.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit had high freeze flow.Root cause: 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 after 23 years.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.Over time, the seating was off.As this device has no record of being serviced in the 23 years of use, this complaint condition is being attributed to wear & tear.Corrective actions the unit was repaired, tested to specification 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
Repair technician stated: "found silicon torn.High freeze flow.15mm should be 10mm".1216677-2020-00176-1 n20 spherical probe 139.(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: 10401885
• Report Number: 1216677-2020-00176
• Device Sequence Number: 2990667
• 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): 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: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/13/2020
• 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