MAUDE Adverse Event Report: COOPERSURGICAL, INC. MITYVAC M-STYLE CUP/UVR

Model Number	10015LP
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
Event or Problem Description
The cup was ruptured during vacuum delivery operation.
Additional Manufacturer Narrative
A review of the two-year product complaint history indicated similar events being reported in the past, although rare.Root cause is indeterminable, it may be that the vad was used in a manner contrary to indicated use.Past investigation analysis has indicated that the cup assembly pull-off force had continuously exceeded the established 41lbs on the subassembly print.A formal analysis could not be performed due to the affected device not being returned.However, if the affected device is returned in the future, the complaint may be reopened and addressed as needed.The assembly process was reviewed, and it was confirmed that no alterations or changes were made.A review of the work order dhr indicated that all process steps were performed with acceptance and did not indicate any abnormality.
Event or Problem Description
The cup was ruptured during vacuum delivery operation.1216677-2019-00107-1 mityvac m-style cup-uvr 10015lp (b)(4).

• Brand Name: MITYVAC M-STYLE CUP/UVR
• Common Device Name: MITYVAC M-STYLE CUP/UVR
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPER SURGICAL, INC; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4401326332
• MDR Report Key: 8378464
• Report Number: 1216677-2019-00107
• Device Sequence Number: 303565
• Product Code: HDB
• UDI-Device Identifier: 00888937003062
• UDI-Public: 888937003062
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K890307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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
• Device Expiration Date: 04/30/2019
• Device Model Number: 10015LP
• Device Catalogue Number: 10015LP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2019
• Supplement Date Received by Manufacturer: 01/19/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2016
• 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