MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 10 MM, 0°; RIGID SCOPE

Model Number	WAIR100A
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that during a therapeutic procedure for detection of sentinel lymph nodes, an incorrect device was provided in the instrument kit (a telescope "ultra", 10 mm, 0° (wa4kl100, sn# (b)(4)) was in the box of the wair100a kit (telescope "ir", 10 mm, 0°)) with the effect that the intended infrared fluorescence examination could not be performed.Instead, a more invasive procedure with a double curage left and right was performed.However, the patient is reportedly well.
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Additional Manufacturer Narrative
Correction: h6 - health effect - clinical code; h6 - medical device problem code.Device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation since it was reported to be working correctly.The reported incident can be attributed to human error since the demo kit was packed incorrectly and thus unsuitable for the intended procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the telescope without showing any abnormalities.The case will be closed on olympus side with no further actions and the reported event/incident will be recorded for trending and surveillance purposes.

• Brand Name: TELESCOPE "IR", 10 MM, 0°
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15063242
• Report Number: 9610773-2022-00283
• Device Sequence Number: 5628155
• Product Code: GCJ
• UDI-Device Identifier: 04042761083621
• UDI-Public: 04042761083621
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WAIR100A
• Device Catalogue Number: WAIR100A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS VISERA ELITE II VIDEO SYSTEM CENTER; OLYMPUS VISERA ELITE II XENON LIGHT SOURCE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown