MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.

Model Number A22041A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the service center for evaluation.The exact cause of the reported event cannot be determined at this time.The oem performed a manufacturing and quality control review for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The subject device and lot number were manufactured november 2011.

Event Description

The service center was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, a part of the instrument broke off and fell into the patient.The patient was being treated for bph (benign prostatic hyperplasia).It is unknown what the doctor was performing when the reported event occurred.The device fragment was retrieved from the patient by using the ellik evacuator which pumps water in and suctions up the tissue as well as the broken piece of the device.There was no bleeding during the therapeutic procedure.No x-ray was needed.No resistance was felt upon insertion.It was not known if there were any other equipment replaced during the procedure.There was no patient injury reported.Additionally, the user facility reported that it was most likely the sheath as well as the alignment and connection of the sheath that were inspected prior to use due to the fact that this particular physician is very conscientious.No anomalies were noted.The sheath was stored on a shelf in a store room.The storage environment does not have heavy light exposure.There are no windows and there is fluorescent lighting.The customer believed that the event occurred due to the age of the resection sheath.

Manufacturer Narrative

This supplemental report is being submitted to provide to correct the previously reported event date of (b)(6) 2018 to (b)(6) 2019.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8946235
• MDR Text Key: 161204244
• Report Number: 9610773-2019-00115
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 11XW-0045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS RESECTION SET, OLYMPUS BIPOLAR PLASMA LOOP