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

Model Number A22201C

Device Problems Break (1069); Detachment Of Device Component (1104); Nonstandard Device (1420)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

Contrary to the information previously supplied, only two hf resection electrodes from the same model and lot were returned to the manufacturer for evaluation/investigation.The visual inspection confirmed that the loop wires at the distal end of the hf resection electrodes are broken off.Olympus america inc.("oai") is implementing a removal action of specified lot numbers of the monopolar hf resection electrodes a22201c and wa22037c.The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.Oai has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes.Investigations have confirmed that loop wires can break during the intended use of the electrodes.As a result, a fragment may fall inside the patient and will need to be retrieved.Retrieval of the fragment could prolong the procedure and, under certain circumstances, could require additional surgical treatment.The investigation revealed that the loop wires of the affected electrodes were damaged during production.The cause of this damage is defective manufacturing equipment.The damaged loop wires cannot be detected by visual inspection.There has been no report to date of an adverse event or patient injury.However, in an effort to prevent a potential risk to patient health, oai is undertaking this action to remove the affected lot numbers.(b)(4).

Event Description

Olympus was informed that during a therapeutic transurethral resection (tur) procedure, the loop wires of six hf resection electrodes from the same lot broke off and fell inside the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was successfully completed with another hf resection electrode and there was no adverse event or patient injury.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°, 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: 6571550
• MDR Text Key: 75455470
• Report Number: 9610773-2017-00073
• Device Sequence Number: 0
• Product Code: FAS
• Reporter Country Code: GM
• PMA/PMN Number: PK931763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: P16Z0001
• Other Device ID Number: 14042761036648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1