MAUDE Adverse Event Report: UNIMAX MEDICAL SYSTEMS INC ENDOMINI DETACHABLE ENDO POCKET; ENDO BAG

Model Number FEP934500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Tears (2516)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

The event has been received to discuss what kind of condition could ripped the patient's skin.It is too less information to complete the analyzation at this case.The initial reporter is communicated to require more detailed event description by mail, but the reporter could not provide any the extent of information.It is no feedback from reporter.The internal investigation is going on.The results will be recorded at the follow up report and it will be provided to fda.

Event Description

While using the endobag to remove the patient's appendix from the abdominal cavity, the endobag ripped the patient's skin.

Manufacturer Narrative

It is not very clear what kind of condition could hurt the skin due to the event information.Considering the material of the endo pouch is elastic material with no sharpe edges and the structure is smooth and rounded.It is a rational discussion.The surgical procedure show that the surgery is performed using other instruments during the removing procedure.The skin injury happened while the surgeon attempted to remove the bag with other instruments from the abdominal cavity, which then applied external force.The skin injury is a kind of clinical side effect when the surgeon attempted to remove the bag from the abdominal cavity,which then applied external force.A review of the device history record (dhr) indicated the device was released meeting all quality release specifications at the time of manufacture.There are no complaints for skin ripped case to be observed.For the user, the symbol "read ifu before use" is shown on the label.The intended use, adverse reactions, instructions for use and warnings/ precautions have been informed in the ifu.The instructions for use present the operation procedure step by step to avoid user error, especially removing bag procedure.The relative information has been described in the ifu : "the following information should be read before using this device." "remove the endo pocket at the end of the laparoscopic procedure.When removing, pull the pocket string out of the trocar until the leading edge of the pocket is inside the tip of the trocar.Grasp the string and the trocar and remove from the access site together, the detachable endo pocket with specimen should be removed through the access site easily.If the pocket with specimen cannot be removed, enlargement of the access site is recommended for easier removal".

Event Description

While using the endobag to remove the patient's appendix from the abdominal cavity, the endobag ripped the patient's skin.

• Brand Name: ENDOMINI DETACHABLE ENDO POCKET
• Type of Device: ENDO BAG
• Manufacturer (Section D): UNIMAX MEDICAL SYSTEMS INC; 8f-2, no 127, lane 235; pao chiao r, hsin tien dist.; taipei city 23144, tw, ; TW
• Manufacturer (Section G): KAIWEI SHENZHEN CO., LTD; 3f,no.1,bin hai ming zhu indus; gon ming town; shenzhen guangdong 518106, ch ; CH
• Manufacturer Contact: hsieh ; 8f-2, no 127, lane 235; pao chiao r, hsin tien dist.; taipei city 23144, tw, ; 28919169
• MDR Report Key: 6434943
• MDR Text Key: 70866423
• Report Number: 3007791595-2017-00003
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/20/2021
• Device Model Number: FEP934500
• Device Catalogue Number: FEP934500
• Device Lot Number: 8251605223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/13/2017
• Event Location: Hospital
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2016
• 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
• Patient Outcome(s): Other