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

Model Number A22041A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the service center for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

The service center was informed that during an unspecified procedure, the ceramic tip of the inner sheath broke off and fell into the patient.The user facility reported the device fragment was removed from the patient.The intended procedure was completed with a similar device.There was no patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation and lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reported that the most probable cause for the reported event is as follows: the legal manufacturer provided a summary of the complaint review and assumed what led to reported issue based on the information provided by the customer.The customer¿s fault description is evaluated as plausible.Based on the damage pattern, we assume that the damage to the insulation insert was induced by thermo-mechanical fatigue.We cannot determine if there was pre-existing damage to the insulation insert or if it was already worn.Furthermore, it cannot be determined if the damage was caused during the last reprocessing of the instrument or during its last use in a procedure.Lost fragments of the ceramic insulation insert can be localized using a suitable x-ray procedure or computed tomography.The item does not meet the product specifications and can no longer be used.The damage to the insulation insert was most likely caused by thermo-mechanical fatigue/wear and tear.Another possible cause is improper handling by the customer, more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.The legal manufacturer reported that dhr review of the subject model: a22041a was not impossible to perform with a missing lot number.Instead, 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 legal manufacturer (oste) will continue to monitor the occurrence rate in the context of our quality management system.If necessary, oste will take further action in the future.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10411578
• MDR Text Key: 223647437
• Report Number: 9610773-2020-00190
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1