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

Model Number	900629
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report forwarded by csi service & repairs team- item 900629 freeze valve is stuck in the open position.Follow-up stated, no patient involvement- item was being tested prior to use on a patient.Ref (b)(4).Ll100 multi tip w-tc 900629 e-complaint (b)(4).
Event or Problem Description
"freeze valve is stuck in the open position".900629 ll100 multi tip wtc e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation review dhr inspect returned samples distribution history: this complaint unit was manufactured at csi on 9/25/2019 under wo (b)(4) and shipped on 10/16/2020.Manufacturing record review: dhr 273067 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 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 units' core valve was faulty.Root cause: the root cause for this complaint condition is being attributed to a faulty core valve, p/n 105519.The lot number associated with this item was noted to have recently been exhausted.Orders consist of 1000 pieces at a time indicating the occurrence is low.Corrective actions the unit was repaired, tested to specifications and returned to the customer.No additional action is required as the occurrence is considered low and the 2 year complaint review has not indicated another core valve failure.Coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.Was the complaint confirmed? yes.

• 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 drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10980613
• Report Number: 1216677-2020-00291
• Device Sequence Number: 3486858
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown