MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; ENDOSCOPE SHEATH, REUSABLE

Model Number A22040A

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/14/2022

Event Type  Injury  

Event Description

The customer reports during a transurethral resection of the prostate (turp) procedure using a 26fr inner and outer sheath, the distal end of the liner broke inside the patient.The physician continued the procedure until he noticed abnormal bleeding.The prostate had been cut by the sharp edge of the broken ceramic.The injury is described as "huge cuts in the prostate.It's hard to evaluate the depth but it caused major bleeding peri-op and post-op." the volume of blood loss was not calculated.There were no procedural or anatomical challenges that could have contributed to the reported event.Treatment/intervention required included nothing more than a foley catheter and standard post-op procedure.The patient's current condition is good.

Manufacturer Narrative

The device referenced in this report has been returned to olympus, but has not yet been evaluated.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation and the legal manufacturer¿s investigation and device history record (dhr) review.New information was added to the following fields: d8, h3, h6, h10.A broken portion of the ceramic insulation was returned along with the device.The distal end of the device was observed and it was noted the ceramic insulation was completely detached from the sheath.The broken portion that was detached from the device was examined and verified that there were two broken portions returned which also has sharp edges.Inspection noted the broken portion returned is the missing portion that completes the entire ceramic insulation.It appeared there were no other missing portions of the ceramic insulation.There were no signs of dents, bends, or deformations.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the insulation tip's damage was 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.As for the technical cause, it is likely the damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, or mechanical impact like fall, shock or similar stress.Also note that the cause of the reported issues is attributed to wear and tear.Signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.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.The instructions for use (ifu) states the following: 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.Olympus will continue to monitor the field performance of the device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• 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: 15030589
• MDR Text Key: 296009690
• Report Number: 9610773-2022-00276
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 19511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• 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?: Yes
• Date Device Manufactured: 06/11/2019
• 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
• Patient Sex: Male