MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

Device Problem Crack (1135)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported conditon.

Event Description

Incident details- the wallach 100 that was just purchased when dr (b)(6) joined parkview cracked yesterday while using on a patient.A midas was to be placed because this caused more of the tissue to be affected then planned.(b)(4).

Manufacturer Narrative

Investigation: x-review dhr.X-inspect returned samples.Analysis and findings: (b)(4).Distribution history: this complaint unit was manufactured at csi on 05/25/2021 under wo #302133 and shipped on 2/25/2022.Manufacturing record review: dhr 302133 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was returned on a repair on rma #334669.Visual evaluation: visual examination of the complaint unit revealed physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: based on the damage this unit was not properly cleaned and appears to have been exposed to a chemical.It is likely an attempt to clean the device had exposed the innards and corroded the white tubing to the point where cracks developed.Root cause is due to end user handling error.It should be noted the ifu instructs the user on how to wipe down and clean the device properly.Fault code: user.Failure code: wear and tear.Correction and/or corrective action the unit was not repairable and sent to sp, a location for scrap processing.No further corrective action is necessary.Preventative action activity.Coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Incident details- the wallach 100 that was just purchased when dr trina chapman smith joined parkview cracked yesterday while using on a patient.A midas was to be placed because this caused more of the tissue to be affected then planned.1216677-2022-00243, ll100 cryosurgical 900001 (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: 15284435
• MDR Text Key: 305501115
• Report Number: 1216677-2022-00243
• 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
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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: 08/08/2022
• 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