MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°; HF-RESECTION ELECTRODES

Model Number A22251A

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The hf resection electrode was not returned to olympus 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.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions but may be reopened if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.In addition, the reported phenomenon will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate in saline (turis-p) procedure, the wire holding the roller at the distal end of the hf resection electrode broke, and the roller detached and fell inside the patient's bladder.The bladder wall was observed to be thin and surgical intervention was associated with an increased risk of perforation, thus the roller was not retrieved.However, it was assumed that it would be excreted naturally, with the patient's urine.The intended procedure was successfully completed with another hf resection electrode and there was no report about an adverse event or patient injury.

Manufacturer Narrative

Additional information: the hf resection electrode was not returned to olympus 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, 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 resection electrode without showing any abnormalities related to function and safety.The case will be closed from olympus side with no further actions, but the reported phenomenon will be recorded for trending and surveillance purposes.

Manufacturer Narrative

Describe event or problem: device evaluation: the suspect medical device was not returned to the manufacturer for evaluation/investigation but to olympus medical systems corporation (omsc), (b)(4).The evaluation/investigation confirmed that the hf resection electrode is damaged.The wire holding the roller at the distal end of the hf resection electrode was found to have separated and was charred on one side and the roller had detached.Furthermore, the fork tubes were found to be deformed.The cause of this damage and the breakage of the electrode wire is mechanical overload in combination with wear and tear.Therefore, this event/incident was attributed to abnormal use/off-label use.In addition, 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 resection electrode without showing any abnormalities related to function and safety.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 informed about the investigation results and retrained to correctly use the olympus medical devices.

Event Description

The roller was excreted naturally, with the patient's urine.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
• 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: 6081332
• MDR Text Key: 59846225
• Report Number: 9610773-2016-00050
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951863
• 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,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22251A
• Device Catalogue Number: A22251A
• Device Lot Number: 14238P01L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• 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