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

Model Number A22040A

Device Problems Break (1069); Crack (1135)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

This report is bring submitted to report the user's experience and investigation findings.Physical evaluation of the returned device confirmed the user's report.The sheath was cracked/broken.Device history record (dhr )review a manufacturing and quality control review was performed for the device> there is no non-conformity associated with this device with respect to the described issue.The dhr review showed that the device was manufactured according to valid instructions and met all specifications.Prior to using medical devices, please ensure they are in perfect technical condition.See also the warnings in the instructions for use (ifu).4 before use warning infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1 inspection and testing inspecting the product: visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches ceramic insulation at distal end: visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G cracks, fractures).Warning risk of injury: 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.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.Cause as for the technical cause, it is assumed that 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.Also note that the cause of the reported issues is attributed to wear and tear.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.Analysis kindly note that the event description and the information provided in the qir report is plausible.Based on the described damage pattern, it can be assumed the insulation tip's damage was caused by mechanical thermal influence.Unfortunately, it cannot be determined with certainty, whether there was a previous damage on the device or any damage on the ceramic insulating insert was caused during last reprocessing or during last usage.The ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.In the case of unclear remains of fracture fragments, of the insulating insert made of ceramic, these can be localized with a suitable x-ray procedure or computer tomography and removed, if necessary.

Event Description

The customer reports, during a transurethral resection of a bladder tumor (turbt) using a 26fr resection sheath set, the physician noticed something was not right about the inner sheath.They thought it was missing a piece, but when they searched the bladder and prostate, they found nothing.About a month and a half later, the patient came back for a repeat turbt.At this time, the physician found a piece of the ceramic tip lodged in the patient¿s prostate.The patient reported pain in the prostate.No further consequences to the patient were reported.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15493430
• MDR Text Key: 300699037
• Report Number: 9610773-2022-00443
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 166W-0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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
• Patient Outcome(s): Other
• Patient Sex: Male