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

Model Number A22040A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned and the lot number remains unknown.As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.The root cause of the reported malfunction cannot be determined at this time as the investigation is ongoing; however, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.

Event Description

Per medwatch report (#(b)(4)), on (b)(6) 2020, "according to the staff, the patient was scheduled for a turp (transurethral resection of the prostate) bipolar procedure.The physician immediately complained that he/she was not able to perform the procedure, because the device would not allow him/her to finish the loop.The physician tried a larger loop electrode.Two broken pieces were noticed in the patient's bipolar pan.These pieces fit on the end of the sheath.The physician asked for a new set of bipolar instruments and was able to finish the procedure." no serious injury, death or infection was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer the legal manufacturer was unable to perform the review of the device history records for this device as no lot number was not provided and no device was returned.However, the manufacturing and quality control review was performed by the legal manufacturer for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining and to inspect the instrument prior to every procedure.In the case of unclear remains of broken fragments of the insulating insert made of ceramic, these can be detected with a suitable x-ray procedure or computer tomography.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the risk.As part of the investigation, olympus followed up with the user facility to obtain additional information.The assistant risk coordinator at the user facility further reported they are unable to determine the lot number.No other devices were replaced in this event.The procedure was completed using a different (unspecified) device there was no delay in the procedure.No fragments fell into the patient.No abnormalities were found when the device was inspected prior to use.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d4, d8, d9, g3, g6, h2, h3, h4, h6 and h10.A visual inspection was performed on the received condition and found damage to the distal end; beak is broken and missing.About 90 percent of the beak is broken causing sharp edges at the tip to which the user is experiencing.The shaft was checked and there are no external damages.The lever at the proximal end was manipulated and the movement is consistent and normal.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining and to inspect the instrument prior to every procedure.In the case of unclear remains of broken fragments of the insulating insert made of ceramic, these can be detected with a suitable x-ray procedure or computer tomography.Olympus will continue to monitor complaints for this device.

• 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: 11153845
• MDR Text Key: 262443810
• Report Number: 9610773-2021-00043
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 66