MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH

Model Number A22040A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

The referenced device was not returned to the manufacturer.No dhr review can be performed as there was no lot number reported; however, the oem performed a review of the manufacturing and quality control review and noted that a rework on the crimp was performed during the manufacturing process and the device was released after the rework.In addition, an ongoing investigation is being conducted to improve the insertion insert long term stability.The cause of the reported event cannot be determined at this time.However, if additional information becomes available or if the device is returned at a later date, this report will be updated accordingly.As a preventive measure, the instruction manual provides warning that states, "impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.".

Event Description

The manufacturer was informed that almost immediately after the set was placed during a transurethral resection of a prostate/bladder tumor (turp/turbt) procedure, the insulation tip at the distal end of the bipolar resectoscope broke off inside the patient's bladder.For several hours, the physician tried to retrieve the device piece with grasping forceps but was unable to retrieve the piece.The patient had a strictured urethra with a frozen pelvis that made the procedure more difficult than normal.The user facility did not have the right equipment in the room for the unexpected event.Therefore, the procedure was canceled and re-scheduled for removal of the foreign body and turbt for (b)(6) 2019.

Manufacturer Narrative

The patient safety clinical coordinator at the user facility further reported that during the (b)(6) 2019 procedure, there was no sparking/arcing observed and no unexpected bleeding to the patient.There was no issue withdrawing the device from the patient.It was unknown if the device (lot# 18yw) was inspected prior to use.It was unknown if any devices were replaced.On (b)(6) 2019, the device fragment was retrieved from the patient's bladder as fluoroscopic guidance was used.The patient reportedly required inpatient care from (b)(6) 2019 - (b)(6) 2019.The patient was discharged.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device history record (dhr) review.Update to section h6.Manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8759129
• MDR Text Key: 149979643
• Report Number: 2951238-2019-00988
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 18YW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELECTRODE: OLYMPUS WA22521C, LOT #1000025437; GENERATOR: OLYMPUS ESG-400, S/N (B)(6); ELECTRODE: OLYMPUS WA22521C, LOT #1000025437; GENERATOR: OLYMPUS ESG-400, S/N (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention