MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The root cause of the reported event cannot be determined at this time.The instruction manual warns users ¿do not insert the instrument into the endoscope if the stopper is not attached to the tube sheath between the tube joint and control section.Otherwise, the clip will extend from the tube sheath.It may also cause the insertion portion of the instrument to extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.¿.

Event Description

Olympus was informed that during an unspecified procedure, the first clip didn't engage from the endoscope and was pulled off the patient¿s tissue.The physician inserted a second to stop the bleeding; however, by the time the clip advanced from the sheath it was bent.It was reported that the bleeding had slowed and the physician decided another clip was not needed.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6124840
• MDR Text Key: 61149869
• Report Number: 2951238-2016-00885
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Catalogue Number: HX-202UR
• Device Lot Number: 66K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• 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