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

Model Number A22040A

Device Problem Crack (1135)

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

Event Date 04/09/2023

Event Type  malfunction  

Manufacturer Narrative

Address: (b)(6).The device was returned and evaluated, and the customer¿s allegations were confirmed; the ceramic tip was damaged.Additionally, the sealing ring was scratched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been almost 1 year since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.Based on the damage pattern of the insulation insert, it is assumed 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.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.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 scratched sealing ring issue was most likely caused by wear and tear and wrong handling by the user.Considering the age of the product, the scratches on the sealing ring most likely constitute signs of wear and tear and are most likely attributable to frequent use and poor maintenance.A scratched sealing ring is very likely to cause the inner sheath to leak.The corresponding warnings in the ifu are as follows: ¿4 before use: warning: infection control risk.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.4.1 inspection and testing 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.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the ceramic tip was damaged on the inner sheath, for 26 fr.Outer sheath.The issue was identified during reprocessing after the procedure.The patient was not under sedation and there was no procedural delay.The procedure was completed with the same device.No patient harm was reported.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 16885796
• MDR Text Key: 314744250
• Report Number: 9610773-2023-01244
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2023

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 22711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2023
• Initial Date FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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: CV-190 EVIS EXERA III VIDEO SYSTEM CENTER