FDA Adverse Event Injury Summary report: N

8010047-2017-01689

MDR report key: 7008672 · Received November 8, 2017

Report

Report Number: 8010047-2017-01689
Event Type: Injury
Date Received: November 8, 2017
Report Date: December 4, 2017
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Product Code: KNS
PMA / PMN Number: PK092309
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE WILL NOT BE RETURNED TO OLYMPUS MEDICAL SYSTEM CORP. (OMSC) FOR INVESTIGATION. OMSC HAS NOT FINISHED THE INVESTIGATION YET. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS REPORT WILL BE SUPPLEMENTED AS SOON AS THE INVESTIGATION IS COMPLETED.

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEM CORP.(OMSC). THEREFORE, OMSC COULD NOT EVALUATE THE REPORTED DEVICE. THE EXACT CAUSE OF THIS ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NO. IS UNKNOWN, THE MANUFACTURING HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES WHICH PASSED THE INSPECTION. FROM THE REPORTED INFORMATION, IT IS ASSUMED THAT THE EVENT DID NOT OCCUR DUE TO MALFUNCTION OF THE DEVICE, BUT OCCURRED AS A GENERAL ACCIDENTAL SYMPTOM OF THE PROCEDURE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WERE BLEEDINGS OF FOUR CASES AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTIONS. OLYMPUS ELECTROSURGICAL KNIFE WAS USED DURING EACH PROCEDURE. AFTER THE PROCEDURE, BLEEDING OCCURRED. THE USER PERFORMED THE HEMOSTASIS TREATMENT. THERE WAS NO PATIENT INJURY REPORTED EXCEPT THE EVENT. NO FURTHER INFORMATION WAS REPORTED. BASED ON THE REPORTED INFORMATION, THERE IS A POSSIBILITY THAT EITHER KD-650 OR KD-612 WAS USED. THIS MDR IS ABOUT THE FOURTH OF THE FOUR CASES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
788213			KNS	OLYMPUS MEDICAL SYSTEMS CORP.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other