MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE RETRIEVAL NITINOL BASKET V; SINGLE USE RETRIEVAL BASKET

Model Number FG-V451P

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an endoscopic retrograde cholangiopancreatography, the subject device was used.When the user retrieved the calculus, the guide wire tip of the subject device was broken.The user removed the subject device from the bile duct and there was bleeding from the bile duct.No additional treatment was reported.The intended procedure was completed with the subject device.The user commented that the basket or the guide wire tip of the subject device might have injured patient's bile duct.This is the report regarding the bleeding from the bile duct.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past three months from the delivery date (may 9, 2019), it was found no irregularities.Based on the past similar cases, omsc presumes that the breakage of the guide wire tip occurred due to the following occurrence mechanism.The user inserted the device into endoscope with a sharp angle between the guide wire tip and the guide wire.The guide wire tip was subjected to a load and broken.Also, omsc could not determine whether the bleeding from the bile duct was attributed to the breakage of the guide wire tip since the subject device was not returned.The above device handling has warned in the instruction manual as follows.*when using the guidewire, insert the instrument with its gw tip parallel to the guidewire while holding the gw tip.Be careful not to forcibly insert the instrument with a sharp angle between the gw tip and the guidewire.This may damage the gw tip.Do not angulate the insertion portion of the endoscope or operate the forceps elevator while the distal end of the insertion portion is extended from the distal end of the endoscope.This could result in perforation, bleeding, or mucous membrane damage.Do not force the distal end of the insertion portion against body cavity tissue.This could result in perforation, bleeding, or mucous membrane damage.

• Brand Name: SINGLE USE RETRIEVAL NITINOL BASKET V
• Type of Device: SINGLE USE RETRIEVAL BASKET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8652524
• MDR Text Key: 146474261
• Report Number: 8010047-2019-02048
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• PMA/PMN Number: K170811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-V451P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other