MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

Device Problems Break (1069); Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

Cracked shaft confirmed complaint: insulator tube and defrost trigger broken.Replaced tube and trigger.Repair order 98311 1216677-2022-00158 ll100 cryosurgical 900001 e-complaint-(b)(4).

Manufacturer Narrative

Investigation: x-inspect returned samples.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at wallach in 1998.The workorder number is not available and the original ship date is not available.Manufacturing record review: the manufacturing dhr is not available for review due to the unit being manufactured in 1998.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 repair log 98311.Visual evaluation: visual examination of the complaint unit revealed that the defrost trigger and insulator tube are broken.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: while no definitive root cause could be reliably determined, the potential cause may be that the unit was dropped or it could be normal wear and tear.Fault code: user.Failure code : wear and tear.Correction and/or corrective action.The complaint unit was repaired and returned to the customer.The defrost trigger and insulator tube were replaced.The unit was tested and found acceptable.Preventative action activity.Coopersurgical will continue to trend this complaint condition.

Event Description

Cracked shaft.Confirmed complaint: insulator tube and defrost trigger broken.Replaced tube and trigger.Repair order (b)(4).1216677-2022-00158, 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: 14515171
• MDR Text Key: 298250828
• Report Number: 1216677-2022-00158
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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: 05/10/2022
• 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