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

Model Number A22040A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been evaluated by olympus.The definitive cause of the customer'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.

Event Description

It is reported during a tumor resection in the bladder procedure using a 26fr sheath, it was noted that the ceramic tip of the device was missing.The tip could not be located in the operating room.An x-ray was performed on the patient and the tip was visualized inside the patient in 3 pieces.During the procedure it was noted the patient had a urethral stricture , so a curved van buran dilator was placed through to the bladder.An incision was then made in the perineum in order for the resectoscope to gain access to the bladder.The resectoscope was placed through the perineum then the distal tip was placed over the dilator that had been placed from above through urethra/bladder and guided to remove bladder tumor.Per the customer, the resectoscope was more than likely torqued on the dilator causing the ceramic tip to crack and break inside the patient.An unspecified time later, the patient was brought back for surgical removal of the retained device fragments.Everything went well with the surgery.This device was inspected prior to use.There was no physical damage to the sheath prior to use and the device did not sustain a deep impact.

Manufacturer Narrative

This report is being submitted to report corrected information.Corrected: b3- date of event is unknown.

Manufacturer Narrative

The report is being updated to report corrected information and investigation findings.Corrected information is reported in b3.B3-date of event: unknown.Physical evaluation of the complaint device confirms the sheath was cracked/broken.With the information provided, it is concluded the most probable cause was due to thermo-mechanical fatigue.Investigation was unable to determine whether there was advanced wear and tear or pre-existing damage.Furthermore, it cannot be determined whether the final damage was triggered in the course of the procedure or during reprocessing.A device history record review was completed for the affected lot number without showing any non-conformities or deviations regarding the described issue.The cause for the reported issue is very likely excessive force by the customer (mechanical overload, impact, drop, fall).Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11021201
• MDR Text Key: 226627395
• Report Number: 9610773-2020-00293
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 18YW 0099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/06/2021; 01/05/2021
• Supplement Dates FDA Received: 01/06/2021; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention