MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, SINGLE USE, 12 PCS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22306D

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.The manufacturing site also performed a dhr review and found no related nonconformances or deviations at the time of product release.As a preventive measure against device breakage, the device instructions for use warns against bending the distal tip and states, ¿the hf-resection electrode is a precise mechanical and electrical device which is very sensitive to mechanical and electrical stress.¿ the instructions for use also warns, ¿the use of damaged equipment, equipment that does not function properly and/or equipment with illegible or missing markings may cause infection, toxic shock, electrical, mechanical and thermal injury and/or unintended nerve stimulation.¿ the instructions for use also have pre-procedure directions for inspecting both the device and its packaging for damage and deformation.

Event Description

Olympus was informed that during a turbt procedure, the tip of the device broke off and fell into the patient.Despite followup attempts by phone and in writing, it is not currently known if the fragment remained in the patient or was successfully retrieved.The procedure was completed with another similar device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, SINGLE USE, 12 PCS
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8066050
• MDR Text Key: 127062575
• Report Number: 2951238-2018-00697
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051689
• UDI-Public: 14042761051689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000023975
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other