MAUDE Adverse Event Report: CONMED ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM D

Catalog Number ESA_5379

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

The complaint device has not been evaluated.A supplemental report will be filed following the completion of the device evaluation and the complaint investigation.

Event Description

During left shoulder rotator cuff decompression arthroscopy, the tip of the ablator came off inside the patient.The doctor opened the patient to try to find the tip and did not see anything in the patient's soft tissue.The operative site was then closed.This report is raised due to a change in procedure.The procedure was changed from arthroscopic to open.

Manufacturer Narrative

The reported device was returned to conmed for evaluation.Visual inspection of the device verified the reported issue of "tip detachment".The tip was broken off and was not returned as it resides in the patient's soft tissue to date.The insulation was noted to have damage, which is exhibited when the device makes unintentional contact with another instrument or cannula.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.(b)(4).A risk analysis was performed and found acceptable.To prevent this potential problem from recurring and to reduce the risk of patient injury, the instruction for use provide the following information.Avoid contact with sharp and metal instruments at all times.Do not activate the electrode while any portion of the electrode is in contact with another metal object.Localized heating of the electrode and the adjacent metal object may result in product damage or patient and/or personal injury.Examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.Use care when inserting into and withdrawing the electrode from a cannula to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the electrode when power is being applied.This may result in an unintended surgical effect, injury, or device damage.This incident type will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ULTRABLATOR 90 DEGREE, THREE RIB, 130MM LENGTH, 3.2MM D
• Type of Device: ULTRABLATOR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7234102
• MDR Text Key: 98781781
• Report Number: 1017294-2018-00004
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: ESA_5379
• Device Lot Number: 863628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1