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

Model Number A22042A

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.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# 2429304-2022-00153.

Event Description

The customer reports during unspecified procedures using a 26fr.Resection sheath, the tip of the sheath broke inside the patient.The shards fell inside the patient, but the physician was able to retrieve all the shards.After the issue, the physician was able to complete the procedure with a similar item without any further issues.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 supplemental report was submitted to provide the results of the legal manufacturer¿s (oste) investigation.The lot number for the subject device is unknown, therefore, a review of the device history records could not be performed.Based on the described damage pattern, it is presumed that the damage to the insulation insert was induced thermally and/or mechanically; therefore, it is most likely attributable to wear and tear and/or improper handling by the customer (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.Lost fragments of the ceramic insulation insert can be localized and removed using a suitable x-ray procedure or computed tomography.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.To mitigate the injury to the patient and also device damage, the instruction for use provides the following: - 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.- visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches.- 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).- 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.Olympus will continue to monitor complaints related to the device and reported phenomenon.

• Brand Name: RESECTION SHEATH, 26 FR.
• Type of Device: HYSTEROSCOPE AND ACCESSORIES
• 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: 15932552
• MDR Text Key: 304984569
• Report Number: 9610773-2022-00598
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other