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); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect medical devices have not yet been returned to the manufacturer 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, if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified therapeutic procedure, the loop wires of two hf resection electrodes from different 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.This is report 1 out of 2.

Manufacturer Narrative

Device evaluation: the suspect medical device 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, 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.Oai's correction number according to 21 cfr 806.10 (c) (1): 2429304-4/18/2017-044r.Fda's recall number: z-2629-2017.

• 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
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg ; 4940669662
• MDR Report Key: 6581021
• MDR Text Key: 75831872
• Report Number: 9610773-2017-00079
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK931763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: A22201C
• Device Catalogue Number: A22201C
• Device Lot Number: P16Y0005
• Other Device ID Number: 14042761036648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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