MAUDE Adverse Event Report: COOPERSURGICAL, INC. 3MM PIPET CURETTE BOX=50

Model Number	MX140
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).
Event or Problem Description
"tip of curette broke off during procedure, took time and use of several instruments but was retrieved no injury to patient." (b)(4).
Additional Manufacturer Narrative
Investigation.Initiated manufacturer's investigation review dhr inspect returned samples.*analysis and findings: the three returned mx140 samples were received and verified to have been completely seal pouched and intact.The three sample were verified to have been free of any damage and were functionally acceptable; all three were tested for vacuum using water.All three samples produced an acceptable vacuum where there were no leaks.The reported event could not be duplicated as reported, this may be considered an isolated incident.The assembly process was reviewed and found acceptable and without alterations.All inventory from the affected lot has been depleted and not available for further verification analysis, no further action required at this time.A review of the two-year product complaint history indicated this to have been the only reported event of its kind, trending will continue for this product.A review of the product lot dhr was performed and no abnormalities were noted.*correction and/or corrective action: corrective action is not applicable due to the absence of the actual affected device for investigative analysis as it was not returned to determine a possible root cause, the other three returned samples were free of any visible damage and functioned in an acceptable manner.Per bsr-qar-026, this complaint will be monitored for trending in that no injury was reported to end user or patient.*was the complaint confirmed? no.
Event or Problem Description
Tip of curette broke off during procedure.Was retrieved, no injury to patient.3mm pipet curette box 50 mx140 (b)(4).

• Brand Name: 3MM PIPET CURETTE BOX=50
• Common Device Name: 3MM PIPET CURETTE BOX=50
• 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: 7952094
• Report Number: 1216677-2018-00051
• Device Sequence Number: 11090608
• Product Code: HHK
• UDI-Device Identifier: 00888937003536
• UDI-Public: 888937003536
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 07/14/2020
• Device Model Number: MX140
• Device Catalogue Number: MX140
• Device Lot Number: 224216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2017
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown