MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 30°, AUTOCLAVABLE; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number WA50373B

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

Patient Problem Full thickness (Third Degree) Burn (2696)

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 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 pediatric surgery procedure, the patient sustained a third-degree burn of the scrotum when the telescope was used to examine a scrotal edema.No further information was provided but the intended procedure was successfully completed with the same set of equipment.In addition, there were no reports of any device malfunctions.

Manufacturer Narrative

Device available for evaluation: device evaluation: the telescope was not returned to olympus for evaluation/investigation since there was no device malfunction.Therefore, the exact cause of the patient's injury and the reported phenomenon could not be determined.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the eligible serial numbers of the telescope without showing any abnormalities.Furthermore, it is clearly stated as a caution note in the instructions for use that light sources emit large amounts of energy.As a result the connectors of the endoscopic equipment and the distal end of the endoscope become hot.Endoscopic equipment must not be placed on the patient¿s skin, on flammable materials or on heat-sensitive materials since otherwise there is a risk of thermal injury to the patient¿s tissue, burns to the patient¿s or user¿s skin or burns or thermal damage to surgical equipment.The user apparently did not follow these instructions since the patient sustained a third-degree burn of the scrotum when the telescope was used to examine a scrotal edema.Therefore, this event/incident was attributed to use error.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.In addition, the user will be informed about the evaluation results and retrained to correctly use the olympus medical devices.

• Brand Name: TELESCOPE, 5.4 MM, 30°, AUTOCLAVABLE
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6978992
• MDR Text Key: 90287120
• Report Number: 9610773-2017-00123
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK923982
• 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
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA50373B
• Device Catalogue Number: WA50373B
• Other Device ID Number: 04042761029582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OLYMPUS LIGHT-GUIDE CABLE (WA03210A OR WA03310A)
• Patient Outcome(s): Required Intervention