MAUDE Adverse Event Report: COOPERSURGICAL, INC. 120MM INSUFF NEEDLE

Model Number	900-200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Ref e-complaint-(b)(4) medwatch5093562.
Event or Problem Description
Per medwatch 5093562 report stated "pneoumo-matic insufflation needle slow to obtain/maintain pneumoperitoneum.Leaking near the white plastic at the top of the device".Ref e-complaint-(b)(4).
Event or Problem Description
Report stated: "pneoumo-matic insufflation needle slow to obtain/maintain pneumoperitoneum.Leaking near the white plastic at the top of the device".1216677-2020-00092-1 900-200 120mm insuff needle (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation, no sample returned, review dhr.Distribution history: the complaint product was purchased from geotec on (b)(6) 19.Manufacturing record review: dhr-900-200 - 265897 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-19-09-11-032 was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record : service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product was not returned to coopersurgical.Visual evaluation: evaluation of the complaint unit could not be completed at the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appending to this investigation.Functional evaluation: evaluation of the complaint unit could not be completed at the complaint unit has not been returned to coopersurgical.If the unit should be returned at a later date, it will be evaluated, and any findings will be appending to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed.Corrective actions: corrective action is not applicable at this time due to the absence of the affected sample for investigative analysis.No further training required at this time; complaint will be monitored for trending.Was the complaint confirmed? no.

• Brand Name: 120MM INSUFF NEEDLE
• Common Device Name: 120MM INSUFF NEEDLE
• 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: 9967242
• Report Number: 1216677-2020-00092
• Device Sequence Number: 11687410
• Product Code: FHO
• UDI-Device Identifier: 00888937003666
• UDI-Public: 888937003666
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K970788
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Expiration Date: 09/11/2022
• Device Model Number: 900-200
• Device Catalogue Number: 900-200
• Device Lot Number: 265897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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