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 10/20/2018

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 during a therapeutic polypectomy of the colon procedure, the patient sustained a perforation of the colon.It is assumed that the patient had a muscle reflex caused by the hf output.Clipping of the perforation was performed as a first-aid treatment.Afterwards, the patient was admitted to (b)(6) university school of medicine (b)(6) hospital for observation.

Manufacturer Narrative

Olympus medical systems corporation (omsc), japan notified us that this case (mfr report number 9610773-2019-00150 ) refers to the same adverse event as mfr report number 9610773-2018-00096.Thus, this case is a duplicate and was created by mistake.Olympus will close this case as non-valid.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: HF- GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9254392
• MDR Text Key: 178780755
• Report Number: 9610773-2019-00150
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS REUSABLE ELECTROSURGICAL SNARE (SD-12U-1)
• Patient Outcome(s): Hospitalization; Required Intervention