MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ZZ**C8702, M ALEXIS LAP SYS W/ KII FIO; KGW

Model Number C8702

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot number is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: laparoscopic anterior bowel resection.The surgeon attempted to extract the alexis retractor from the patients abdomen.And the mid draping sheet teared off and slipped off inside the abdomen.Surgeon has complained that tearing of the sheath should not have happened patient status: n/a.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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.

• Type of Device: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7184706
• MDR Text Key: 97776862
• Report Number: 2027111-2018-00013
• Device Sequence Number: 1
• Product Code: KGW
• UDI-Device Identifier: 00607915125721
• UDI-Public: (01)00607915125721(17)200615(30)01(10)1298995
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/15/2020
• Device Model Number: C8702
• Device Catalogue Number: 101135901
• Device Lot Number: 1298995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2017
• Patient Sequence Number: 1