FDA Adverse Event Other Summary report: N

TELESCOPE, 10MM, 0 DEGREE, HD, AUTOCLAVABLE

MDR report key: 2773529 · Received September 26, 2012

Report

Report Number: 9610773-2012-00083
Event Type: Other
Date Received: September 26, 2012
Date of Event: November 16, 2011
Report Date: November 16, 2012
Manufacturer: OLYMPUS WINTER & IBE GMBH
Product Code: FBP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED TO MFR FOR INVESTIGATION, BUT HAS BEEN INSPECTED BY THE LOCAL SALES AND SERVICE ORGANIZATION WITHOUT OBSERVATION. AS THE PRODUCTS OF OTHER MANUFACTURERS TOO, THE VIDEOTELESCOPE HEATS UP AT THE DISTAL END DURING LIGHT EMISSION. THE HEATING-UP EFFECT OF THE WA53000A IS NEVERTHELESS IN CONFORMANCE TO THE REQUIREMENTS OF (B)(4). IT CAN BE CONSIDERED BASIC KNOWLEDGE FOR MEDICAL PROFESSIONALS TO SWITCH-OFF THE VIDEOTELESCOPE WHEN NOT IN USE, ESPECIALLY WHEN IT IS PUT ASIDE OR ON THE PT. FOR THAT PURPOSE AND TO MEET CUSTOMER EXPECTATIONS REGARDING USABILITY, THE PRODUCT IS EQUIPPED WITH A STAND-BY MODE. APPROPRIATE WARNING MESSAGE ARE INCLUDED IN THE IFU. THE EVENT IS AN OBVIOUS CONSEQUENCE OF A USE ERROR WITH RATHER MINOR (TEMPORARY) CONSEQUENCES. THE CASE WILL BE CLOSED WITHOUT FURTHER ACTIONS.

Description of Event or Problem · 1

THE PHYSICIAN PERFORMED A LAPAROSCOPIC OOPHOROCYSTECTOMY. DURING THE PROCEDURE, THE PT SUFFERED A SKIN BURN ON HER THIGH, AS THE DOCTOR HAD PUT THE DEVICE IN A POCKET OF THE DRAPE WITHOUT SWITCHING THE LIGHT OFF. THE DOCTOR CARRIED OUT TREATMENT OF THE BURNS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TELESCOPE, 10MM, 0 DEGREE, HD, AUTOCLAVABLE	OLYMPUS VIDEOTELESCOPE	FBP	OLYMPUS WINTER & IBE GMBH	WA53000A

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Hospitalization