MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 22.5 FR.

Model Number WA22810A

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the outer sheath, 22.5 fr.Exhibited a burnt distal tip.The issue occurred during reprocessing for a therapeutic laser vaporization of prostate procedure and the procedure was completed.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h6.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the suggested event occured due to wrong handling / improper handling on the part of the user.The event can be prevented/detected by following the instructions for use which state: note when the laser fiber¿s guiding pin within the adapter¿s narrow groove faces downwards, the laser beam will be emitted from the underside of the laser fiber.Caution risk of damaging the inner sheath the inner sheath¿s distal end may be damaged if the laser fiber¿s tip is retracted into the sheath too early.To minimize this risk, use the adapter wa22870a together with a compatible laser fiber.Danger risk of death or serious injury improper use of lasers can cause burns, eye damage, and explosions.Thoroughly review the laser safety information included in the system guide endoscopy.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to g2 to provide information that was inadvertently not included in the initial medwatch.

• Brand Name: OUTER SHEATH, 22.5 FR.
• Type of Device: OUTER SHEATH, 22.5 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18923518
• MDR Text Key: 337897453
• Report Number: 9610773-2024-00759
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761051729
• UDI-Public: 04042761051729
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22810A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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