MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF RESECTION SHEATH

Model Number A22040A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Olympus was informed that toward the end of the resection procedure, the tip of the device broke off in the sheath and possibly fell onto the pt's bladder.The device fragment was observed when the pt's bladder was flushed out.It was reported that the intended procedure was completed with another similar device.A ct scan was performed an no device fragment was found.There was no injury reported.Olympus followed up with the user facility regarding the reported event via telephone and in writing to obtain additional info, but with no results.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported incident could not be conclusively determined at this time.If additional info becomes available at a later time, this report will be supplemented.

• Brand Name: HF RESECTION SHEATH
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4380462
• MDR Text Key: 5240044
• Report Number: 2951238-2014-00628
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

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: A22040A
• Device Catalogue Number: A22040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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