MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V; DESKTOP LIGHT SOURCES

Model Number WA97020A

Device Problems Device Operates Differently Than Expected (2913); Inadequate Lighting (2957)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience 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.

Event Description

Olympus was informed that during an unspecified therapeutic endoscopic procedure, the light source malfunctioned.As a result, the operating field was not illuminated anymore and the endoscopic procedure had to be converted to open surgery.Furthermore, it was reported that another light source of the same model was not functioning either.

Manufacturer Narrative

There was no device returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, it was reported that the light source did not actually malfunction during the procedure.In fact, the illumination of the operating field was merely perceived as insufficient.Another light source of the same model present in the operating room was not used since it was not expected to provide sufficient illumination.In addition, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the light source without showing any abnormalities related to function and safety.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results, the intended use of the light source and its technical limitations.

Manufacturer Narrative

Device evaluation: the light source was returned to olympus for evaluation/investigation.When the device was inspected and tested, it was found to be in good working order and in accordance with its specifications.No abnormality, defect, failure or malfunction was found during the performance tests.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, it was reported that the light source did not actually malfunction during the procedure.In fact, the illumination of the operating field was merely perceived as insufficient.Another light source of the same model present in the operating room was not used since it was not expected to provide sufficient illumination.In addition, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the light source without showing any abnormalities related to function and safety.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results, the intended use of the light source and its technical limitations.

• Brand Name: LIGHT SOURCE "OLYMPUS CLL-V1", LED, 110-230 V
• Type of Device: DESKTOP LIGHT SOURCES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): EN ELECTRONICNETWORK HAMBURG GMBH; meiendorfer strasse 205; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6759403
• MDR Text Key: 81585868
• Report Number: 9610773-2017-00097
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA97020A
• Device Catalogue Number: WA97020A
• Other Device ID Number: 04042761077613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention