FDA Adverse Event Malfunction Summary report: N

THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

MDR report key: 5707868 · Received June 8, 2016

Report

Report Number: 8010047-2016-00745
Event Type: Malfunction
Date Received: June 8, 2016
Date of Event: May 11, 2016
Report Date: July 29, 2016
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Product Code: GEI
PMA / PMN Number: K111202
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

Additional Manufacturer Narrative · 1

THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2016-00745 TO PROVIDE ADDITIONAL INFORMATION BASED ON THE EVALUATION OF THE DEVICE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. DEVICE MANUFACTURER DATE WAS IDENTIFIED. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. AS A RESULT OF EVALUATION OF OMSC ON JULY 8, 2016, THERE WAS NO MALFUNCTION WHICH CAUSED OR MIGHT CAUSE THE FRAGMENT TO FALL INSIDE THE PATIENT. THEREFORE, WE ARE RETRACTING MDR.

Description of Event or Problem · 1

THE SUBJECT DEVICE WAS USED DURING AN UNCERTAIN PROCEDURE. AFTER FIVE MINUTES USE, THE PTFE PAD OF THE TOP OF THE DEVICE WAS DETACHED. THE PROCEDURE WAS CONTINUED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360403	THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP	THUNDERBEAT HANDPIECE	GEI	OLYMPUS MEDICAL SYSTEMS CORP.	TB-0535FC	56K

Patients

Seq	Age	Sex	Outcome	Treatment
1