MAUDE Adverse Event Report: COOPERSURGICAL, INC. MYSTIC; EXTRACTOR, VACUUM, FETAL

Model Number	10057
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A mushroom vacuum instrument broke during an instrument-assisted delivery.Details provided from delivery note: " a total of 3 pulls were performed, and 2 popoffs occurred.Two reapplications were performed.With the third pull, the mushroom vacuum handle broke, with cup left on the fetal head, which was removed.The fetal head had made some descent.After the vacuum broke, pushing continued with just maternal expulsive efforts with contractions." no harm came to the patient or newborn.

• Brand Name: MYSTIC
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 9902792
• Report Number: 9902792
• Device Sequence Number: 16797367
• Product Code: HDB
• UDI-Device Identifier: 00888937003109
• UDI-Public: (01)00888937003109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020
• Report Date (Section F): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 10057
• Device Lot Number: 271719
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75
• Date Report Sent to FDA: 02/26/2020