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

Model Number A22251C

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not yet 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 device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

Olympus was informed that during an unspecified procedure, the roller at the distal end of the hf resection electrode broke off and fell inside the patient's bladder.No fragment remained inside the patient, since the roller was reportedly retrieved by unknown approach.No further information was provided and it is unknown if and how the intended procedure was completed.However, there was no adverse event or patient injury.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation, since it was reportedly discarded by the user facility.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 may be reopened if additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the event/incident will be recorded for trending and surveillance purposes.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 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 ; 40 66966
• MDR Report Key: 5395350
• MDR Text Key: 37343614
• Report Number: 9610773-2016-00005
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K903323
• 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
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 14146P02L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2014
• 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