MAUDE Adverse Event Report: MEDLINE RENEWAL ULTRASONIC SCALPELS

Model Number HAR36M

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

The device in question was not returned for evaluation.It cannot be confirmed that the device was reprocessed.However, the lot number was provided, and a review of the reprocessing records was performed.All processes were conducted as required prior to release.The reported issue was could not be confirmed, as the device was not returned.The user facility confirmed that the pad was retrieved from the patient at the time of the procedure; general anesthesia was used; however there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident we do not have enough information to determine the root cause of the failure at this time, however if more information is provided then this report will be updated.However, in an abundance of caution, we are filing this medwatch report.

Event Description

We received a report indicating while using a reprocessed harmonic scalpel, the black tissue pad located on the distal tip, detached during use.

• Brand Name: ULTRASONIC SCALPELS
• Type of Device: ULTRASONIC SCALPELS
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756 ; 5415164206
• MDR Report Key: 6640780
• MDR Text Key: 77554844
• Report Number: 3032391-2017-00016
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: HAR36M
• Device Lot Number: 321575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention