MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; RESECTOSCOPE SHEATH

Model Number A22041A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a 24 fr resection sheath, the sheath broke and device fragments remained inside the patient (the doctor was not able to retrieve them).There were no adverse effects to the patient as a result of the retained device fragments.The patient was scheduled for a second surgical procedure approximately three months later to remove the device fragments (successfully completed).The patient is expected to make a full recovery.

Manufacturer Narrative

This report is being submitted to report information provided by the customer and investigation findings.Date of original surgery (b)(6) 2021 , date of device fragment retrieval surgery (b)(6) 2022.The device was not returned to olympus for evaluation, the investigation is based on information reported by the customer.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 device was sold in october of 2016.The instructions for use (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.Prior to using medical devices, please ensure they are in perfect technical condition.See also the warnings in the instructions for use (ifu).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.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.Device history record (dhr) review a manufacturing and quality control review was performed for device a22041a with reported lot number 168w-0114.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.Conclusion: the definitive cause of the reported event cannot be specified.However based on investigation findings: as for the technical cause, it is presumed 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.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00371.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTOSCOPE 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: 14026943
• MDR Text Key: 292592888
• Report Number: 9610773-2022-00127
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 168W-0114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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; Required Intervention