MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number HX-201UR-135L.A

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/17/2014

Event Type  Injury  

Manufacturer Narrative

The device reference in this report has been discarded by the user facility and will not be returned to olympus for evaluation.The exact cause of the user's experience could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that during an esophagogastroduodenoscopy (egd) procedure, the clips were prematurely closing and the physician had difficulty deploying the clip through the sheath, as it was taking two hands to close the clip.It was noted that during the end of the egd procedure, before the clip exchange, the pt began to bleed severely.The clips were exchanged and the procedure was completed using another device.The pt was transported to the hospital and was admitted for a 4-5 days for an inpatient stay and was given 2 units of blood.No further information has been provided as to the current status of the pt at this time.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: SINGLE USE ROTATABLE CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3767363
• MDR Text Key: 15881773
• Report Number: 2951238-2014-00142
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-201UR-135L.A
• Device Catalogue Number: HX-201UR-135L.A
• Device Lot Number: 31K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 109