MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 100...120 V~,; HF- GENERATORS

Model Number WB991046

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that some days after a therapeutic polypectomy procedure of the large intestine, the patient returned to the user facility because of abdominal pain and fever.A ct was performed and revealed a perforation.The patient was then transferred to another hospital for the treatment of the perforation.Clipping was performed and the patient is currently recovering.There was no report about a malfunction of any of the olympus medical devices.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.There were no reports of any malfunction of the generator and the device is still being used by the user facility.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: HF- GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 8411961
• MDR Text Key: 138519194
• Report Number: 9610773-2019-00056
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (y/n): N
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB991046
• Device Catalogue Number: WB991046
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS EVIS LUCERA ELITE LIGHT SOURCE CLV-290; OLYMPUS EVIS LUCERA ELITE SYSTEM CENTER CV-209; OLYMPUS REUSABLE ELECTROSURGICAL SNARE SD-5U; OLYMPUS EVIS LUCERA ELITE LIGHT SOURCE CLV-290; OLYMPUS EVIS LUCERA ELITE SYSTEM CENTER CV-209; OLYMPUS REUSABLE ELECTROSURGICAL SNARE SD-5U
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR