MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 10 MM, 0°; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number WA4KL100

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

Patient Problem Burn, Thermal (2530)

Event Date 03/22/2019

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 at the beginning of a therapeutic coelioscopy procedure, the patient sustained a skin burn in the epigastric area caused by the metal junction between the telescope and the light-guide cable.The size of the burn is approx.1 cm x 5 cm.The degree of the burn is unknown.No further information was provided.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be conclusively determined and is being judged as unknown.However, there were no reports of any malfunction of the telescope.In addition, there are relevant caution notes in the instructions for use stating that light sources emit large amounts of energy and that as a result, connectors of the endoscopic equipment and the distal end of the endoscope may become hot.Hence the reported phenomenon can most likely be attributed to use error.Furthermore, 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 related to function and safety.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: TELESCOPE "ULTRA", 10 MM, 0°
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8734312
• MDR Text Key: 149188214
• Report Number: 9610773-2019-00074
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04042761082846
• UDI-Public: 04042761082846
• Combination Product (y/n): N
• PMA/PMN Number: K150633
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA4KL100
• Device Catalogue Number: WA4KL100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention