MAUDE Adverse Event Report: COOPERSURGICAL, INC. LL100 MULTI TIP W/TC

Model Number 900629

Device Problems Crack (1135); Electrical /Electronic Property Problem (1198); Material Twisted/Bent (2981)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currenlty iinvestigating the reported conditon.

Event Description

Ambient temp shows 16 deg.C, not 21 deg.C.Timer randomly starts counting up when the gun is not active confirmed complaint: thermocouple damaged at blue connect and tube tip.Inlet defrost tube bent and cracked.Damaged insulator.Repair order 97362 1216677-2022-00063 ll100 multi tip w-tc 900629 e-complaint-(b)(4).

Event Description

Ambient temp shows 16 deg.C, not 21 deg.C.Timer randomly starts counting up when the gun is not active.Confirmed complaint: thermocouple damaged at blue connect and tube tip.Inlet defrost tube bent and cracked.Damaged insulator.Repair order (b)(4).Ll100 multi tip w-tc 900629, (b)(4).

Manufacturer Narrative

Investigation: x-inspect returned samples : analysis and findings: complaint 9 (b)(4).Distribution history: this complaint unit was manufactured in 2001.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: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was returned on repair log 97362.Visual evaluation: visual examination of the complaint unit revealed physical damage to the blue thermocouple connector, the tube tip, the insulator tube and the inlet tube.Functional evaluation: complaint unit was functionally evaluated and found not to function properly.Root cause: given the age of the device and the damage the root cause is being attributed to wear and tear.Correction and/or corrective action.The unit damage and age made a repair unfeasible and therefore it was scrapped out per the customer's direction.The customer purchased a new unit.No further corrective action is necessary preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: LL100 MULTI TIP W/TC
• Type of Device: LL100 MULTI TIP W/TC
• 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: 13757037
• MDR Text Key: 291286894
• Report Number: 1216677-2022-00063
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813024
• 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
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900629
• Device Catalogue Number: 900629
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: No
• 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