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

Model Number	900629
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by csi service & repair team- "would not defrost." ref (b)(4).Ll100 multi tip w-tc 900629 e-complaint: (b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples inspect stock product.Distribution history: this complaint unit was manufactured at csi on 10/31/2018 under wo (b)(4) and shipped on 6/7/2019.Manufacturing record review: dhr 257978 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.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 complaint unit did not display temperature.Root cause: the thermocouple wire was not connected internally.The unit will operate producing a cold tip, but the temperature would not display.Assembly error.Corrective actions the unit was repaired, tested to specifications and returned to the customer.Several units from fg were pulled to inspect.Four units found to have various issues by service & repair.Units to be re-worked.The training records were updated for current assembler.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.Was the complaint confirmed? yes.
Event or Problem Description
"would not defrost".900629 ll100 multi tip wtc e-complaint (b)(4).

• Brand Name: LL100 MULTI TIP W/TC
• Common Device Name: LL100 MULTI TIP W/TC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 11148302
• Report Number: 1216677-2020-00314
• Device Sequence Number: 10923193
• Product Code: GEH
• UDI-Device Identifier: 00888937009866
• UDI-Public: 888937009866
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K813024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900629
• Device Catalogue Number: 900629
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown