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

Model Number A22201A

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

There was no device 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 a 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 event/incident will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that after a therapeutic transurethral resection of the bladder tumor (turbt) procedure, it was noticed that the loop wire at the distal end of the hf resection electrode had broken off and was missing.It is unknown when this damage occurred and whether the fragment broke off and fell inside the patient.No further information was provided but the turbt procedure was successfully completed with the same set of equipment and there was no report about an adverse event or patient injury.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°
• 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: 6416570
• MDR Text Key: 70546814
• Report Number: 9610773-2017-00048
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK790071
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22201A
• Device Catalogue Number: A22201A
• Other Device ID Number: 04042761021302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1