MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

Leaking.Confirmed complaint: leaking high pressure line to valve body.Leaking valve body o rings.Bent trigger levers.Repair log (b)(4).Ll100 cryosurgical 900001 e-complaint- (b)(4).

Manufacturer Narrative

Investigation.X-review dhr.X-inspect returned samples.Analysis and findings.Complaint (b)(4).Distribution history: the complaint product was manufactured at csi on 06/05/2017 under work order (b)(4) and sold on 06/23/2017.Manufacturing record review: dhr-223019 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 98645 this unit was at csi on 06/16/2022.Visual evaluation: visual examination of the complaint product revealed physical damage.The trigger levers were bent.Functional evaluation: complaint unit was functionally evaluated and found to not function properly.Root cause: the root cause of this issue has been attributed to the high pressure line and orings leaking.This is attributed to normal wear and tear on the unit.Correction and/or corrective action.The complaint unit was repaired and returned to the customer.The high pressure fitting to the valve was tightened, the orings were replaced and the trigger levers were adjusted.The unit was tested and found acceptable.*preventative action activity.Coopersurgical will continue to trend this complaint condition.

Event Description

Leaking.Confirmed complaint: leaking high pressure line to valve body.Leaking valve body o rings.Bent trigger levers.Repair log 98645.1216677-2022-00211 ll100 cryosurgical 900001 e-complaint-(b)(4).

• Brand Name: LL100 CRYOSURGICAL
• Type of Device: LL100 CRYOSURGICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 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: 15084747
• MDR Text Key: 304706931
• Report Number: 1216677-2022-00211
• Device Sequence Number: 1
• Product Code: GEH
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other