MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

Device Problems Break (1069); Leak/Splash (1354); Component Missing (2306); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

Customer stated "will not hold pressure".Repair tech stated "leaking valves and o rings in gun, defrost actuator missing, broken gauge housing and cover - not repairable - scrapped per meagan" repair order # (b)(4).1216677-2021-00032 ll100 cryosurgical 900001 e-complaint (b)(4).

Manufacturer Narrative

Investigation: inspect returned samples: distribution history: this complaint unit was manufactured at csi in 1995.Manufacturing record review: a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.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.Visual evaluation: visual examination of the complaint unit revealed a lot of physical damage.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: the root cause of this issue has been attributed to wear and tear.Corrective actions: the unit was extensively damaged and deemed unrepairable.The customer confirmed it can be discarded.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Was the complaint confirmed? yes.

Event Description

Customer stated: "will not hold pressure".1216677-2021-02-0000317-1 900001, ll100 cryosurgical (b)(4).

• Brand Name: LL100 CRYOSURGICAL
• Type of Device: LL100 CRYOSURGICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate dr; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 95 corporate dr; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11515244
• MDR Text Key: 258932249
• Report Number: 1216677-2021-00032
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00888937010077
• UDI-Public: 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• 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: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• 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