MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8313, XXS ALEXIS WND PROT/RET 5/BX; KGW

Model Number C8313

Device Problem Material Perforation (2205)

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

Event Date 02/14/2018

Event Type  malfunction  

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.

Event Description

Procedure performed: revision of gastric sleeve.Event description: "dr (surgeon) inserted the xxs alexis as part of a trial of the novel approach in clinical trial for specimen removal of the gastric sleeve approach.Dr did not take off the housing of the cannula initially and alexis was difficult to insert fully and so dr pulled out the device with a toothed grasper from the housing before reinserting back into cannula without the housing.Dr inserted his fingers throughout the removal of specimen due to larger portion of stomach and toothed graspers to facilitate removal.Alexis was visible torn when surgeon removed it from the abdomen." type of intervention: unk.Patient status: unk.

Manufacturer Narrative

Investigation summary: the event unit was not returned to applied medical for evaluation.Based on the description of the event, engineering determined that the sheath tore when the event device was removed from the trocar with a toothed grasper.The technique described in the customer experience is an off-label use of the device and is not stated within the device's instructions for use as a method of inserting the device.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: C8313, XXS ALEXIS WND PROT/RET 5/BX
• Type of Device: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7343906
• MDR Text Key: 103090439
• Report Number: 2027111-2018-00087
• Device Sequence Number: 1
• Product Code: KGW
• Combination Product (y/n): N
• PMA/PMN Number: K041711
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C8313
• Device Catalogue Number: 101355501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2018
• Patient Sequence Number: 1