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

Model Number A22040A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted to provide information reported in mw5107603 and investigation findings.Since the product for this info complaint was not returned to olympus, the investigation is based solely on the information provided in mw5107603.Additional information could not be pursued due to lack of contact information.Analysis please note that the event description is plausible.The ceramic tip broke in the bladder of the patient.It should be mentioned that no statement could be made about the damage to the patient, as there was no available information.The following was stated in the evaluation: when considering that the small device fragment was located in the bladder, it is not likely that the device fragment would cause a serious injury.Standard practice after an invasive bladder procedure often includes continuous bladder irrigation for 12-24 hours to ensure any bleeding post procedure does not form clots and cause an obstruction.This would likely "rinse" the device fragment from the patient's bladder.Even if continuous bladder irrigation was not used after the procedure, the patient would likely pass the fragment naturally through the process of urination.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.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 issue is attributed to wear and tear.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.Risk analysis the risk to patients, users, and/or third parties associated with the reported issue is acceptable.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the ifu, a suitable replacement device must be provided during an application.Dhr review it is impossible to perform a dhr review if the lot number is unknown or missing.However, the manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.

Event Description

Olympus received mw5107603 reporting a small black object was noted in the bladder during a procedure and was thought to be the tip of the olympus resectoscope being used.There is no report of adverse effects to the patient as a result of this occurrence.Olympus is unable to request additional information as no contact information was provided in the mw report.

• 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: 14164527
• MDR Text Key: 298964590
• Report Number: 9610773-2022-00146
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• 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: Unknown
• Patient Sequence Number: 1