MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; LAPAROSCOPE, GYNECOLOGIC

Model Number WA50042A

Device Problem Output Problem (3005)

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

Event Date 12/09/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable had poor contact and an occasional flashing screen.The issue was found during reprocessing.There were no reports of patient harm.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: the cable unit was faulty.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the cable unit was faulty causing a purple image.The following non-reportable malfunctions were found during the device evaluation: the charged coupled device¿s cover glass had cracks, the outer tube was faulty causing an abnormal image and the cable unit was scratched.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• Brand Name: VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
• Type of Device: LAPAROSCOPE, GYNECOLOGIC
• 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: 18376089
• MDR Text Key: 331363735
• Report Number: 9610773-2023-03726
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 04042761074971
• UDI-Public: 04042761074971
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50042A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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-290