MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 12 PCS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22302D

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the complaint for broken off loop.The loop wire was broken off, and char marks were also found on both the blue and yellow filters.There was no other damage to the device.The manufacturing site also performed a dhr review and found no related nonconformances or deviations at the time of product release.A potential cause for the breakage is contact between the loop wire and metal during activation.As a preventive measure, 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 turp procedure, the distal loop of the device broke off and fell into the patient¿s bladder while the device was being used on prostate tissue.The physician could not immediately locate the broken off fragment, and it was not known if the fragment remained in the patient or was removed along with the tissue intended to be removed from the patient.The current location of the fragment is unknown.There was no reported patient injury or additional bleeding, and the patient is currently reported to be in good condition.The device and associated equipment had been inspected prior to use with no anomalies found, and there were no reported device assembly issues or bending of the distal tip prior to the event.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 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: 8030115
• MDR Text Key: 125907175
• Report Number: 2951238-2018-00663
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: P16Y0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/01/2018
• 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