MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2022

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the olympus repair center.The repair inspection the reported issue was confirmed, the ceramic insulation at the distal tip of the sheath had cracks.Additionally, the sheath failed the leak test due to a damaged/chipped sealant ring.The legal manufacturer (oste) performed a review of the device history records and no non-conformities or deviations were observed regarding the described issues.The device had not been repaired in the past year.The legal manufacturer¿s (oste) investigation determined that there is no design, manufacturing, material or processing related cause for the reported event.However, based on the damage pattern, it is presumed that the damage to the insulation insert was induced thermally and/or mechanically; therefore, it is most likely attributable to wear and tear and/or improper handling by the customer (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).It cannot be determined 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.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.Lost fragments of the ceramic insulation insert can be localized and removed using a suitable x-ray procedure or computed tomography.The damaged sealant ring was most likely due to wear and tear and or improprer handling.Considering the age of the device, the damage to the sealing ring most likely constitutes to signs of wear and tear and is likely attributed to frequent use and poor maintenance.Olympus will continue to monitor complaints related to the device and reported phenomenon.To mitigate the injury to the patient and also device damage, the instruction for use provides the following: 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.Visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches.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).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.If the product is damaged or does not function properly, contact an olympus representative or an authorized service center.

Event Description

Olympus (osh) was informed that the ceramic tip from the resection sheath was found damaged.It was reported the ceramic insulation tip at the sheath¿s distal end had cracks and did not fall into the patient¿s body as the problem was discovered during inspection before use.The user facility finished the procedure with another device.No death or injury and no impact to person or other was reported to olympus.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16125533
• MDR Text Key: 308455628
• Report Number: 9610773-2023-00140
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 111W-0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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
• Treatment: OLYMPUS MODEL: CV-190.