MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, SPOON, WITH SUCTION CHANNEL, 5 X 330 MM; HF ELECTRODES, RIGID

Model Number A6294

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bowel Burn (1756); Hemorrhage/Bleeding (1888); Burn, Thermal (2530)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The suspect medical device has not yet been returned to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience 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 an unspecified therapeutic procedure, the patient's colon was unintentionally burned and it started to bleed after the damaged insulation of the hf electrode came into contact with the colon tissue.The operating surgeon stopped the bleeding by coagulation and the intended procedure was successfully completed with the same set of equipment, avoiding contact with further colon tissue.

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for investigation but to olympus medical systems corporation (omsc), (b)(6) (returned to (omsc) on 2017-07-25).The visual inspection and the insulation test performed in the cause of the evaluation confirmed that the subject device is within the standard and meets its specification.Furthermore, there is no significant damage (e.G.Scratches or dents) visible on the insulation at the distal end of the subject device.The cause of the patient¿s outcome is most likely a wet insulation.This resulted in a higher frequency output which came in contact with the patient¿s tissue and caused the burn injury of the colon.Therefore, this event/incident was attributed to use error.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the hf-electrode without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: HF-ELECTRODE, SPOON, WITH SUCTION CHANNEL, 5 X 330 MM
• Type of Device: HF ELECTRODES, RIGID
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer (Section G): BOWA-ELECTRONIC GMBH & CO. KG; heinrich-hertz-strasse 4-10; gomaringen
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 6685514
• MDR Text Key: 79027514
• Report Number: 9610773-2017-00091
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A6294
• Device Catalogue Number: A6294
• Device Lot Number: 931957
• Other Device ID Number: 04042761009997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2009
• 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
• Treatment: CONMED ELECTROSURGICAL GENERATOR SYSTEM 2450
• Patient Outcome(s): Required Intervention