MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL-CO2 CRYOSURGICAL SYS

Model Number	900161
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Per customer: leaking from the housing/handpiece.Per tech: confirmed: leaking at damaged endcap insulator.Repair log: (b)(4).Ll-co2 cryosurgical sys 900161 (b)(4).
Event or Problem Description
Leaking from housing/handpiece.1216677-2021-00129-1 ll-cp2 cryosurgical sys 900161 (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples *analysis and findings: complaint (b)(4).Distribution history: this complaint unit (s/n (b)(6)) was manufactured at csi on 03/23/2017 under wo #(b)(4) and shipped on (b)(6) 2017.Manufacturing record review: dhr 200634 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: there is no record for this unit.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 physical damage to the end cap and a broken handle.Functional evaluation: complaint unit was functionally evaluated and found to not function properly.Root cause: the root cause for this complaint condition is being attributed to end user handling error.*correction and/or corrective action 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.

• Brand Name: LL-CO2 CRYOSURGICAL SYS
• Common Device Name: LL-CO2 CRYOSURGICAL SYS
• 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: 12011296
• Report Number: 1216677-2021-00129
• Device Sequence Number: 14466176
• Product Code: GEH
• UDI-Device Identifier: 00888937009804
• UDI-Public: 888937009804
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K803311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 900161
• Device Catalogue Number: 900161
• 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: 06/16/2021
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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