MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS LITHOTRIPTOR HANDLE

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause for the reported event cannot be determined at this time.

Event Description

Olympus received a voluntary medwatch (mw5070367) report that indicates during an endoscopic retrograde pancreatography (ercp) procedure, the lithotripter handle/crusher failed (model/serial number unspecified).A rescue handle was used and the wire was cut by the surgeon to complete the procedure.No device fragment fell into the patient.No bleeding was reported.There was no patient injury reported.Additionally, the device was inspected prior to use with anomalies found.

• Brand Name: OLYMPUS LITHOTRIPTOR HANDLE
• Type of Device: OLYMPUS LITHOTRIPTOR HANDLE
• 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: 6716197
• MDR Text Key: 80145342
• Report Number: 2951238-2017-00458
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1