MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CENTURION; OB BASIC DELIVERY INSTRUMENT TRAY

Model Number	MNS11885
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Filing for initial report, investigation is ongoing.Centurion has not received any additional information regarding this report.Based on the information currently available, centurion is unable to determine if the medical intervention that was performed was necessary to prevent permanent impairment/damage or if a serious injury occurred.
Event or Problem Description
Forceps popped open during procedure and patient's membrane receded into the uterus; dilation and curettage needed to be performed.

• Brand Name: CENTURION
• Common Device Name: OB BASIC DELIVERY INSTRUMENT TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; 100 centurion way; williamston MI 48895
• MDR Report Key: 9317245
• Report Number: 3004519921-2019-00002
• Device Sequence Number: 2578754
• Product Code: LRP
• UDI-Device Identifier: 10653160324614
• UDI-Public: (01)10653160324614(10)2019032090(17)230831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2023
• Device Model Number: MNS11885
• Device Lot Number: 2019032090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other