FDA Adverse Event Malfunction Summary report: N

SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

MDR report key: 11788757 · Received May 7, 2021

Report

Report Number: 8010047-2021-05970
Event Type: Malfunction
Date Received: May 7, 2021
Date of Event: April 7, 2021
Report Date: May 7, 2021
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Product Code: LFL
PMA / PMN Number: K111202
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY, A PART OF THE TISSUE PAD WAS PEELED AWAY. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE RESULTS OF CONFIRMATION OF THE DEVICE AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE REPORTED EVENT MIGHT BE THE FOLLOWING: ULTRASONIC ENERGY WAS DELIVERED WITH NO TISSUE PRESENT BETWEEN THE CLOSED GRASPING SECTION AND THE DISTAL END OF THE PROBE. WE PRESUME THAT THE TISSUE PAD WAS WORN AWAY AND A PART OF THE TISSUE PAD WAS PEELED AWAY DUE TO THIS CAUSED. THE ABOVE DEVICE HANDLING HAS BEEN WARNED IN THE INSTRUCTION MANUAL.

Description of Event or Problem · 1

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT FROM THE USER. DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE SUBJECT DEVICE WAS USED. AFTER ABOUT 1 HOUR SINCE THE SURGERY BEGAN, THE SUBJECT DEVICE COULD NOT BE USED DUE TO THE SEPARATED TISSUE PAD OF THE TOP OF THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OMSC FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN AND SEPARATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
690242	SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP	INSTRUMENT	LFL	OLYMPUS MEDICAL SYSTEMS CORP.	SB-0535FC	11K

Patients

Seq	Age	Sex	Outcome	Treatment
1