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

Model Number A42011A

Device Problems Break (1069); Defective Component (2292)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that when using a resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs, the connection with the work handle was not tight, and the joint was leaking.The event occurred during the therapeutic procedure (electrosurgical resection of uterine polyps) and was completed with the same device.There was no procedural delay or no patient harm associated with the event.The device was returned and evaluated, and upon estimation, the ceramic tip was damaged.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation (leaking joint) was not confirmed.In addition to the damaged ceramic tip, additional evaluation findings were as follows: the sealing ring was damaged, and the tension ring was corroded and discolored.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to h6 problem code.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation and the observed damage pattern, it is likely the damage to the insulation insert was induced thermally and/or mechanically because of wear and tear and/or improper handling by the customer (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).Olympus 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.A definitive root cause cannot be identified.The event can be detected/prevented by following the instructions for use which state: ¿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 field performance for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17389537
• MDR Text Key: 320674158
• Report Number: 9610773-2023-01978
• 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,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A42011A
• Device Lot Number: 171W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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: WA22367A WORKING ELEMENT, PASSIVE, FOR RESECTION