MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8502, M ALEXIS LAP SYS 6/BX; KGW

Model Number C8502

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed the complainant's experience of a tear in the sheath.Based on the condition of the returned unit, it is likely that the reported event was caused by instruments that were used during the procedure.Engineering determined that the damage to the sheath was caused by outward stretching of the film from the puncture hole.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.This report represents the initial and final report.

Event Description

Procedure performed -lap hemi colectomy."this alexis was noticed that it was torn, when the scrub nurse unpack and check the product before use, during the surgery." patient status- no patient injury or illness occurred that was associated with the complaint event.

• Brand Name: C8502, M ALEXIS LAP SYS 6/BX
• Type of Device: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7049795
• MDR Text Key: 93445590
• Report Number: 2027111-2017-02121
• Device Sequence Number: 1
• Product Code: KGW
• UDI-Device Identifier: 00607915119935
• UDI-Public: (01)00607915119935(17)181014(30)01(10)1256507
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: C8502
• Device Catalogue Number: 101357101
• Device Lot Number: 1256507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1