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

Model Number WA22306D

Device Problem Burst Container or Vessel (1074)

Patient Problem Internal Organ Perforation (1987)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

The hf resection electrode was not returned to olympus for evaluation/investigation since it was reportedly discarded by the user facility.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, it is clearly stated as a warning note in the instructions for use that if the distal end of the resectoscope is in contact with oxyhydrogen gas, igniting the plasma causes an explosion.Furthermore, it is pointed out that the plasma must not be ignited if the distal end of the resectoscope is in contact with oxyhydrogen gas.Therefore, the event/incident is an expected and foreseeable side effect, clearly identified in labeling and risk assessment with justification of benefit.The case will be closed from olympus side with no further actions but the reported phenomenon will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the bladder tumor in saline (turis-bt) procedure, an explosion occurred inside the patient's bladder when the high-frequency output of the esg-400 electrosurgical generator was activated.At the same time, external abdominal pressure was applied to the anterior wall to provide vision and to reach the bladder tumor.As a result of the explosion, the patient sustained a bladder perforation and bleeding occurred.The bladder was washed out to clear vision and the perforation was repaired by unknown approach.No further information was provided but the patient is reportedly doing well post procedure.

• 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 ; 4940669662
• MDR Report Key: 6123874
• MDR Text Key: 60749388
• Report Number: 9610773-2016-10006
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial

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 Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Other Device ID Number: 14042761051689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/23/2016
• 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: HF UNIT "ESG-400" (WB91051W); TURIS RESECTOSCOPE
• Patient Outcome(s): Hospitalization; Required Intervention