MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

Model Number UES-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

We received the following report.During a turis (transurethral resection in saline) plasma vaporization, the subject device was used.Gas was found and an explosion occurred when the footswitch of the device was pressed.The patient's bladder was ruptured.The procedure was terminated.Laparotomy was carried out to suture the bladder and the patient was transferred to icu for observation.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.When we checked the examination result of the subject device of the repair center in china, we found that the following.*there was no malfunction on the subject device.The manufacturing record was reviewed and found no irregularities.According to the literature, it is known that gas may occur during the procedure of turis, and a small explosion may occur because of the gas rarely.From the reported information and the examination result, we presume that the reported complication was not due to the malfunction of the device, but occurred as a general complication of the procedure.The above device handling has warned in the instruction manual as follows.*gases that accumulate during tur/is (transurethral resection) and tcr/is (transcervical endometrial resection) are flammable.These gases may ascend into the roof of the bladder and the upper part of the uterus and may come in contact with the electrode.Activating the hf current while flammable gases are present may cause the gases to ignite or explode.This can result in bladder perforation or puncture, exogenous burns, or other injury.Do not activate the hf current while the distal end of the resectoscope is located in the accumulated gases or in their direct vicinity.Evacuate or move the gases or allow the gases to escape from the bladder or uterus as necessary before activating the hf current.

• Brand Name: ELECTROSURGICAL UNIT
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8815136
• MDR Text Key: 151849413
• Report Number: 8010047-2019-02634
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 08/31/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 56