MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation process is completed a follow-up report will be filed.(b)(4).

Event Description

Customer stated "broken freeze trigger." (b)(4).

Event Description

Customer stated "broken freeze trigger".Reference repair order #(b)(4).Ref: (b)(4).

Manufacturer Narrative

Reference: (b)(4).Investigation: x-review dhr.X-inspect returned samples.Analysis and findings: distribution history: this complaint unit was manufactured at csi on 3/29/18 under wo #239015 and shipped on 6/26/18.Manufacturing record review: dhr 239015 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 attached 2-year complaint history showed similar reported complaint conditions.Most tend to be much older units and damaged.Product receipt: the complaint unit was returned on a repair under warranty.However, based on log 92486, this unit was at csi on 7/25/19.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the trigger was stuck.The release lever was not disengaging the locking lever (freeze mode).Root cause : no definitive root cause for this issue could be reliably determined at this time.This unit was fully functional at assembly and in the field for over a year before the issue arose.The repair was an adjustment to the releasing lever to disengage the locking lever from the 'on' position.Correction and/or corrective action the unit was repaired, tested and returned to the customer under warranty.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.Preventative action activity coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: LL100 CRYOSURGICAL
• Type of Device: LL100 CRYOSURGICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8982738
• MDR Text Key: 157847565
• Report Number: 1216677-2019-00253
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• PMA/PMN Number: K803311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other