MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES; LIGHTSOURCE

Model Number WA91502A

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

It was reported the light source had foreign material inside the battery case.It is unknown when this occurred.There were no reports of patient harm.A request for additional information is in progress.

Manufacturer Narrative

The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES
• Type of Device: LIGHTSOURCE
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19193595
• MDR Text Key: 341726209
• Report Number: 9610773-2024-30198
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04042761073592
• UDI-Public: 04042761073592
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

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: WA91502A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• 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