MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number A70942A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 07/03/2019

Event Type  Injury  

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.

Event Description

Olympus was informed that during an unspecified procedure, the patient sustained a thermal burn of an unknown degree and in an unknown area.No further information was provided but there was no report about any malfunctions of the olympus medical devices.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the evaluation was performed exclusively on the basis of the provided information.Possible causes for the reported phenomenon are as follows: the distal end of the telescope may become hot after prolonged illumination.Direct contact or close proximity of the heated part may cause a thermal injury to the patient tissue.The distal end of the telescope emits intense light.Prolonged exposure to the intense illumination in cavities with small lumens may cause a thermal injury to the patient¿s tissue.There are appropriate caution notes in the instructions for use.Hence the reported phenomenon does not represent a malfunction and was caused by use error.Therefore, this event/incident was attributed to use error.However, 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 from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8797643
• MDR Text Key: 151270984
• Report Number: 9610773-2019-00078
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761010559
• UDI-Public: 04042761010559
• Combination Product (y/n): N
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: A70942A
• Device Catalogue Number: A70942A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1