MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HANDHELD, ART, SKIN HARVESTING SYSTEM

Catalog Number ART0001

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that during skin harvesting from the patient's left anterior thigh, the scatter light on the art (autologous regeneration of tissue) handheld device went flashing.The handheld device was turned off and per report, when the device was turned back on, both the scatter and harvest buttons were now flashing and the cartridge could not be removed from handheld device.An additional skin harvest was required using a back-up art handheld device.The procedure successfully completed with three harvests scattered to the patient's circular scalp wound (approximately 3 x 3 cm and 0.5 cm deep).It was denied that additional local anesthesia was required or another skin-harvesting site was needed for the extra harvest.There was no serious injury, medical intervention or follow-up care reported related to the event.Due to the reported incident and need for additional harvest, this medwatch is being filed.The sample was returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the cartridge could not be removed from the art (autologous regeneration of tissue) handheld device and patient required an additional skin harvesting cycle.

• Type of Device: HANDHELD, ART, SKIN HARVESTING SYSTEM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8233003
• MDR Text Key: 132958971
• Report Number: 1417592-2018-00151
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ART0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 59