MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G6313, L ALEXIS O C-SEC RET 5/BX; KGW

Model Number	G6313
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed - lower segment caesarean section.Incision size measured- 12.5 cm.Alexis inserted and rolled down.Yellow placement ring was folded inwards, obstructing the operating field.Whilst baby was delivered, alexis came out of situ.When reinserting alexis o c section, it would not stay in place.Another alexis o c section was used.Type of intervention - another alexis o c section was used.Patient status -did a patient injury or illness occur associated with the complaint event? no.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant's experience could not be replicated or confirmed and there were no visible non-conformances.When the inner ring was compressed, it returned to its original circular shape when it was released.Although the exact root cause of the reported event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: G6313, L ALEXIS O C-SEC RET 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7049734
• Report Number: 2027111-2017-02120
• Device Sequence Number: 11121923
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)200613(30)01(10)1298996
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: Other
• Device Expiration Date: 06/13/2020
• Device Model Number: G6313
• Device Catalogue Number: 101356801
• Device Lot Number: 1298996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1