MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 CRYOSURGICAL

Model Number 900001

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

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event Description

Hose leaks near strain relief at handle connection.(b)(4).Confirmed complaint:leaking.High pressure fitting with in the handles.Ll100 cryosurgical 900001.E-complaint- (b)(4).

Manufacturer Narrative

Investigation inspect returned samples distribution history: this complaint unit was manufactured in 2004.Manufacturing record review: a review of the device history 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 quality release specifications.Should the device history record be located going forward this complaint will be amended accordingly.Incoming inspection review: not applicable.Service history record: this unit was returned over the 17 years of service for damage to the handle and the i/e freeze ss tubing.Historical complaint review: a review of the 2-year complaint history showed similar reported complaint condition.Product receipt: the complaint unit was returned on a repair.Visual evaluation: visual examination of the complaint unit revealed no physical damage.Worn nib on the n2o seal was detected.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Service & repair confirmed the complaint unit had a leak within the handle where the high pressure line fitting connects to the main valve body.Root cause: no definitive root cause for this issue could be reliably determined at this time.This unit has a history of damage requiring repairs with parts replaced exposing the inner valve body with no mention of an issue with the fitting.Given the age of the device there is the potential for normal wear and tear contributing to the loose fitting.Corrective actions the unit was repaired, tested to specifications and returned to the customer.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No further training at this time.Was the complaint confirmed? yes.

Event Description

Customer stated: "hose leaks near strain relief at handle connection".1216677-2021-00124 900001 ll100 cryosurgical (b)(4).

• Brand Name: LL100 CRYOSURGICAL
• Type of Device: LL100 CRYOSURGICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 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: 11948537
• MDR Text Key: 262964058
• Report Number: 1216677-2021-00124
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 04/27/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other