MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR.

Model Number A22251C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the service center for evaluation.The oem (oste) conducted a review of the device history records (dhr) for the affected lot or serial number and indicated there was no deviations or non-conformities regarding the described issue.A visual inspection was performed on the received condition and found the roller ball tip at the distal tip of the device was detached/broken off; the detached roller ball was returned.Additionally the loop wire was broken off as one side of the loop wire from the gray colored insulation was completely missing.A microscope inspection of the distal tip found charred marks at the breakage points of the detached roller ball tip, loop end and grey insulation post.The outer sheath from the proximal end area was noted bent.Based on the device evaluation results and similar reported events, the potential cause of the broken / detached roller ball and the broken / missing loop wire on the device can occur when there is contact between the loop wire / roller ball tip and a metal object during activation the bent outer sheath is due to excessive stress and force cause by mishandling.

Event Description

The manufacturer was informed that during a therapeutic procedure, when device was activated the roller ball at the distal tip of the device broke off and fell inside the patient.All broken parts were retrieved from the patient without harm.There was no patient injury reported.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR.
• Type of Device: HF-RESECTION ELECTRODE, ROLLER
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9239373
• MDR Text Key: 165558305
• Report Number: 9610773-2019-00147
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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 Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 1000032328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• 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