MAUDE Adverse Event Report: COOPERSURGICAL, INC. 1.0MM CRVD MICRO W/TC

Model Number	147
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc, is currently investigating the reported condition.
Event or Problem Description
Hand piece gets cold.Order: 94625.The hand piece handle was freezing to the surgeons gloves.Also the hand piece tip was cold to touch.Ref e-complaint-(b)(4).1 0mm crvd micro w-tc 147 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples distribution history: this complaint unit was manufactured at csi on 6/30/2014 under wo (b)(4) and shipped on 7/31/2018.Manufacturing record review: dhr 162072 was reviewed and no non-conformities were noted.Incoming inspection review: not applicable.Service history record: this unit was returned in july 2019 for a damaged delivery line and again in october 2019 for no seating.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 no seating and low flow.Root cause: the low flow was addressed by replacing the filter (p/n 20446).It also addressed the no seating condition.A clogged filter is an indication the unit was likely inadvertently laying in the liquid in an autoclave.This can occur if the end with the filter (the connector) slips off the tray and into the fluid.Intake of moisture will impact proper function of this device.Including the filter.Compounded by the fact that this device is a micro probe utilizing a very small tube to convey the gas the root cause is being attributed to end user 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? yes.
Event or Problem Description
Customer stated: "hand piece gets cold.Order: the hand piece handle was freezing to the surgeons gloves".147 1.0mm crvd micro wtc e-complaint (b)(4).

• Brand Name: 1.0MM CRVD MICRO W/TC
• Common Device Name: 1.0MM CRVD MICRO W/TC
• 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: 10560927
• Report Number: 1216677-2020-00215
• Device Sequence Number: 11540693
• Product Code: HQA
• UDI-Device Identifier: 00888937004243
• UDI-Public: 888937004243
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/08/2023

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: 147
• Device Catalogue Number: 147
• 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: 09/01/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 02/08/2023
• 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