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 11/01/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.Physical evaluation of the returned device: confirmed the user¿s report: broken beak found.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2429304-2022-00142.

Event Description

The customer reports during a cystoscopy and transurethral resection of a bladder tumor (turbt) for the indication of bladder tumor using a 26fr sheath, the tip of the sheath broke off and fell into the patient¿s bladder.The procedure had just begun, the resectoscope was being used for approx.2-3 min when the device broke.The device fragments fell into the patient's bladder and were retrieved with forceps.The patient did not experience any adverse effects related to this occurrence.The patient's current condition is described as: the patient was not harmed; the biopsy was preformed, and the patient was transferred to pacu and to home in stable condition.There were no anatomical or procedural challenges that could have contributed to the device breaking.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it is likely 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.Furthermore, it can be assumed that the insulation tip's damage was caused by mechanical thermal influence.It cannot be confirmed whether there was previous damage on the device or any damage on the ceramic insulating insert caused during the last reprocessing or during last usage.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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¿.¿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 authorised service centre¿.Olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15885280
• MDR Text Key: 304510151
• Report Number: 9610773-2022-00570
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 17XW-0149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG