MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL; CRYOSURGICAL SYSTEM

Model Number 900001

Device Problems Mechanical Problem (1384); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the repair center, that there was a possible leak and the device has a bad trigger.No adverse event was reported.No patient involvement.No additional information is available.900001 ll100 cryosurgical 2023-06-0000101.

Manufacturer Narrative

Distribution history: the complaint product was manufactured at csi on 31/dec/2014 under work order 169964 and sold on 19/jan/2015.Manufacturing record review: dhr-169964 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no service history record found for this product.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint conditions.Product receipt: the complaint unit was returned on a repair.However, based on log 100470 this unit was at csi on 06/jun/2023.Visual evaluation: visual examination of the complaint product revealed no physical damage.Functional evaluation: complaint product was functionally evaluated and found to function properly.Root cause: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.The unit was tested and found acceptable.The unit was returned to the customer.

Event Description

No additional information is available.

• Brand Name: LL100 CRYOSURGICAL
• Type of Device: CRYOSURGICAL SYSTEM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651582
• MDR Report Key: 17125519
• MDR Text Key: 317866304
• Report Number: 1216677-2023-00093
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 888937010077
• UDI-Public: (01)888937010077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: 1014078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1