MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22041A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2022

Event Type  Injury  

Event Description

Medsun uf report #(b)(4): the customer reported during an unspecified procedure, a cystoscopy sheath broke off in the patient's bladder.The device fragment was retrieved.Multiple requests for additional information from the customer have been unsuccessful.The customer has not responded to date.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.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#2429304-2022-00028.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer's investigation.New information was added to the following fields: d1, d2, d4, d9, g4, h6, h10.D4: since the original model number is unknown, this model was chosen on the bases of the cystoscopes that were mainly procured for the customer.The device history records (dhr) for this device could not be reviewed since the lot number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to thermal mechanical overload, improper handling, or mechanical impact like fall, shock or similar stress.It is noted that signs of fatigue or pre-damage, such as minute cracks, are often difficult to spot.It cannot be determined whether there was previous damage on the device or any damage on the ceramic insulating insert was caused during the last reprocessing or during the last usage of the device.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.The ifu states the following: 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.Olympus will continue to monitor the field performance of the device.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 15234918
• MDR Text Key: 298004640
• Report Number: 9610773-2022-00330
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Male