FDA Adverse Event Other Summary report: N

OLYMPUS ROTATABLE CLIP FIXING DEVICE

MDR report key: 1586120 · Received January 22, 2010

Report

Report Number: 8010047-2010-00013
Event Type: Other
Date Received: January 22, 2010
Date of Event: November 23, 2009
Report Date: November 23, 2009
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
Product Code: KOG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO GATHER ADD'L INFO REGARDING THE EVENT, HOWEVER, ONLY LIMITED INFO WAS PROVIDED. AN OLYMPUS REP HAS VISITED THE USER FACILITY AND CONDUCTED AN IN-SERVICE REGARDING THE APPROPRIATE USE OF THE DEVICE. THE CLIPS SAID TO HAVE BEEN USED DURING THE PROCEDURE WERE DISCARDED IMMEDIATELY FOLLOWING THE PROCEDURE, AND WERE NOT AVAILABLE FOR EVALUATION. THE USER FACILITY RETURNED FIVE UNOPENED BOXES OF UNUSED CLIPS TO OLYMPUS FOR EVALUATION. THE RETURNED SAMPLES ARE BEING FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVALUATION. IF FURTHER SIGNIFICANT ADD'L INFO IS OBTAINED, THE REPORT WILL BE UPDATED. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT CONCLUSIVELY BE DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CLIPS REPORTEDLY DID NOT DEPLOY PROPERLY AND DID NOT RELEASE OFF OF THE PT TISSUE. WHEN THE PHYSICIAN ATTEMPTED TO FREE THE CLIP, THE TISSUES REPORTEDLY TORE. THE PROCEDURE WAS NOT COMPLETED, AND THE PT WAS TAKEN TO SURGERY. THE CURRENT CONDITION OF THE PT IS UNK. NO FURTHER DETAILED INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS ROTATABLE CLIP FIXING DEVICE	CLIP FIXING DEVICE	KOG	OLYMPUS MEDICAL SYSTEMS CORPORATION	HX-201UR-135L	97K

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK