MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES G6313, L ALEXIS O C-SEC RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number G6313

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.Also, this report is a follow-up report for medwatch report number: mw5092808.

Event Description

Name of procedure being performed: c-section.Detailed description of event: during the procedure the alexis sheath tore in the middle.It is unknown if other instruments were used within the alexis.There were no remnants from the tear.Finished case with the device and removed.All material was retrieved.There was no patient injury.Photos are not available.The device will be returned.Medwatch received via mail on 20feb2020.Medwatch report number: mw5092808.Date fda received: 05feb2020."voluntary 06-feb-2020 12:23:28.00: alexis o c-section protector/retractor clear plastic tore during a c-section procedure under normal use.Fda safety report id# (b)(4)." patient status: no patient injury.Type of intervention: completed the case with the same device.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear in the sheath.Based on the condition of the returned unit, it is likely the reported event was caused by the instrumentation that was used during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is a follow-up report to medwatch report number: mw5092808.

Event Description

Name of procedure being performed: c-section.Detailed description of event: during the procedure the alexis sheath tore in the middle.It is unknown if other instruments were used within the alexis.There were no remnants from the tear.Finished case with the device and removed.All material was retrieved.There was no patient injury.Photos are not available.The device will be returned.Medwatch received via mail on 20feb2020.Medwatch report number: mw5092808.Date fda received: 05feb2020."voluntary 06-feb-2020 12:23:28.00: alexis o c-section protector/retractor clear plastic tore during a c-section procedure under normal use.Fda safety report id# (b)(4)." patient status: no patient injury.Type of intervention: completed the case with the same device.

• Brand Name: G6313, L ALEXIS O C-SEC RET 5/BX
• Type of Device: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9771891
• MDR Text Key: 181762961
• Report Number: 2027111-2020-00395
• Device Sequence Number: 1
• Product Code: KGW
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129(17)220923(30)01(10)1368997
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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 Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: G6313
• Device Catalogue Number: 101356801
• Device Lot Number: 1368997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1