MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SINGLE USE LIGATING DEVICE; LIGATING DEVICE (POLY LOOP)

Model Number HX-400U-30

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

The physician placed the polyloop around the intended polyp.When the nursing staff attempted to deploy the polyloop, the polyloop could not be deployed since the sliding bar was bent.The nursing staff cut the outer sheath of the polyloop, and the doctor removed the scope from the patient leaving the polyloop and the sheath in situ.The doctor re-scoped the patient and using the loop cutter cut the loop free from the sheath.The polyloop remained after the sheath was removed.The consultant did not finish the intended procedure after the incident as he did not want to administer any more sedative to the patient.As the procedure has gone on a lot longer than anticipated he recommended that the patient be kept in overnight and the patient be brought back tomorrow to finish the procedure.

Manufacturer Narrative

The exact cause of the polyloop failed to deploy could not be conclusively determined since the subject device was not returned to olympus medical systems corp.(omsc).This report will be supplemented if any important, additional information is obtained, or the subject device is returned and any significant evaluation result is obtained.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: LIGATING DEVICE (POLY LOOP)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4235557
• MDR Text Key: 21845091
• Report Number: 8010047-2014-00648
• Device Sequence Number: 1
• Product Code: KGE
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 41K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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