MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 30°, STERILE, SINGLE USE, 12 PC; HF-RESECTION ELECTRODES

Model Number A22205C

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

Patient Problem Burn(s) (1757)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation as it was reportedly discarded by the user facility.Therefore the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, a material or quality problem can be excluded as a manufacturing and quality control review was performed for the affected lot number of the hf resection electrode without showing any abnormalities related to function and safety.Furthermore, none of the olympus medical devices used during the procedure showed any malfunction.However, it was reported that the single-use hf resection electrode had been reprocessed and reused on the patient.Therefore this event/incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be retrained to correctly use the olympus medical devices.

Event Description

Olympus was informed that during an unspecified therapeutic transurethral procedure, the patient sustained severe burns in the penis and urethra.No further information was provided but none of the olympus medical devices used during the procedure showed any malfunction.In addition, the intended procedure was reportedly completed with the same set of equipment and the patient was released the next day.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 30°, STERILE, SINGLE USE, 12 PC
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov, 75124 ; EZ 75124
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5301289
• MDR Text Key: 33598320
• Report Number: 9610773-2015-00061
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K790071
• 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
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: A22205C
• Device Catalogue Number: A22205C
• Device Lot Number: 13073P03L001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR