MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE; HF-RESECTION ELECTRODES

Catalog Number WA22306D

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

The suspect medical device was not returned to the manufacturer for evaluation/investigation as it was reportedly discarded by the user facility after the procedure.Therefore the exact cause of the patient's outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed as basic data of article identification (lot number) are missing.In general, the occurrence of nerve and muscle stimulation during electrosurgical procedures is an expected and foreseeable side effect, clearly identified in labeling and risk assessment with justification of benefit.In addition, none of the olympus medical devices used during the procedure showed any malfunction.The case will be closed from olympus side with no further actions but may be reopened if additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the event/incident will be recorded for trending and surveillance purposes.Olympus submits this event/incident as a medical device report (mdr) in abundance of caution.

Event Description

Olympus was informed that the patient suffered from bleeding during a therapeutic transurethral resection of the bladder tumor (turbt) procedure.An unintended stimulation of the unblocked right obturator nerve resulted in a reflex, which caused the hf resection electrode to slip and injure the patient's bladder wall.The resulting bleeding was reportedly treated and it was confirmed that no perforation of the bladder occurred.The intended procedure was subsequently completed using the same set of equipment.No further information was provided but none of the olympus medical devices used during the procedure showed any malfunction.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°, STERILE, SINGLE USE
• 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: 5038263
• MDR Text Key: 24359279
• Report Number: 9610773-2015-00042
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 08/28/2015

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 Catalogue Number: WA22306D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS ESG-400 ELECTROSURGICAL GENERATOR
• Patient Outcome(s): Required Intervention