MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION ELECTROSURGICAL UNIT

Model Number UES-40

Device Problem Use of Device Problem (1670)

Patient Problem Burn, Thermal (2530)

Event Date 06/18/2010

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.There was no abnormality found on the subject device.Because burns occurred on patients with another maker's device at the facility, the burn on the patient might be related to the facility's handling of device such as patient-plate.Olympus stated the endorsed patient plates and the appropriate handling of the patient plate in the instruction manual of ues-40.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this supplemental report is required.Omsc was informed that during two unspecified procedures using ues-40 on (b)(6) 2010 and on (b)(6) 2016, burns occurred on patients.The burn occurred on (b)(6) 2010 was mild, and the burn on (b)(6) 2010 was with radial blisters on his skin.Detailed information was not provided from the facility, but the facility report that burns had occurred several times during surgeries, and the burns had also occurred with devices of another maker (valley lab).This mdr is the report of the event on (b)(6) 2010.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6244728
• MDR Text Key: 64576064
• Report Number: 8010047-2017-10006
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UES-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2010
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other