MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 26 FR.

Model Number A22042A

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The white insulation tip at the distal end of the resection sheath (26 french) reportedly broke off inside the patient's bladder during a transurethral resection of a bladder tumor procedure.The patient was under general anesthesia and the procedure was delayed approximately 5 minutes to retrieve the broken piece with a grasper and to obtain a new resection set tray.The procedure was completed without further issue.No death/injury to the patient was reported.Additionally, the lot number is illegible and no device will be returned for evaluation; user facility utilizes third party vendor for repairs and the facility steam sterilizes (autoclaves) the device at 270f for 5 minutes.

Manufacturer Narrative

The legal manufacturer could not performed the device history records for the subject device due to no lot number, however, a review of the the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.The investigation was completed by the legal manufacturer and determined that the most probable cause of the damage of the insulation material of the sheath was caused by thermal mechanical overload, wear and tear, improper handling, the use of excessive force, mechanical impact like fall, shock or similar stress.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.Third-party procedure or repair: olympus cannot comment on the error pattern of the damaged insulating insert.This is probably a case of third-party intervention/repair.There is no evidence of who repaired it and how.Customers that opt for a less expensive repair outside the olympus organization will forfeit any warranty and recourse claims.Olympus assumes no liability for third-party interventions/repairs.As stated on the ifu (instruction for use) and as a preventive measure, the user manual indicates 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.The legal manufacturer will continue to monitor the field performance of this device.

Event Description

Update: additional information this has occurred on three occasions.Case with patient identifier (b)(6) reports occurrence 1 of 3.Case with patient identifier (b)(6) reports occurrence 2 of 3.Case with patient identifier (b)(6) reports occurrence 3 of 3.

Manufacturer Narrative

This report is being updated to provide additional information in b5, and updated information in b1 and h1 medical safety assessment of this reported event was completed.It was determined this event meets the definition of serious injury due to the requirement for retrieval of device fragments to preclude harm.This event has been reported by the importer on mdr# 2429304 - 2022 - 00152.

Manufacturer Narrative

This report is being supplemented to provide further information based on the legal manufacturer's final investigation (per tier 1 investigation requirements).Per the previous investigation, based on further investigation, the reported issue was likely caused by by thermal mechanical overload, wear and tear, improper handling, the use of excessive force.In addition, the reported event was also likely caused by improper reprocessing.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 authorized service center.¿ corrections: d8 - information has been added to d8 that was inadvertently not included on the previous submissions g3 - correction to g3 of the initial medwatch.The aware date should be 19may2021 h6 - codes added to investigation findings that were inadvertently not included on the previous submissions h6 - investigation conclusion code corrected to 4315 olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 26 FR.
• Type of Device: RESECTION SHEATH
• 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: 12095557
• MDR Text Key: 268144652
• Report Number: 9610773-2021-00184
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020985
• UDI-Public: 04042761020985
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2023

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: A22042A
• Device Catalogue Number: A22042A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/01/2021; 09/28/2022; 01/31/2023
• Supplement Dates FDA Received: 07/02/2021; 12/07/2022; 02/14/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: OLYMPUS A22022A (OUTER SHEATH. 28FR); OLYMPUS WA22367A (BIPOLAR WORKING ELEMENT); OLYMPUS WA2T430A (30DEG SCOPE); OLYMPUS WB91051W (HIGH FREQUENCY GENERATOR)