MAUDE Adverse Event Report: ACCU-LINE PRODUCTS INC. ACCU-LINE; SURGICAL MARKING SYSTEM

Model Number P-1RLNS

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2019

Event Type  Injury  

Event Description

Avid medical is the manufacturer of a custom procedure tray ref: stva014-04, custom knee arthroscopy, that includes the following component: marker, skin ruler & 6 labels, vendor part # p-1rlns manufactured by accu-line products inc.Avid medical received a complaint on 04/19/19 originated by phil moran, deputy facility chief supply chain officer, of st.Cloud va health care system.The complaint states that during a knee arthroscopy procedure, the medical team observed on the monitor screen purple "floaters" or flakes believed to be from the skin marker in direct contact with the surgical wound.The surgeon uses the skin marker to indicate the incision line.The complaint component was not available for further evaluation.Avid medical issued formal complaint # (b)(4) to the manufacturer accu-line products inc concerning the flaking of the skin marker for item# p-1rlns, mfg lot# 80109.However, avid medical discovered the site has since went out of business.No patient injury was reported.The medical team stated that "we irrigated the wound thoroughly.".

• Brand Name: ACCU-LINE
• Type of Device: SURGICAL MARKING SYSTEM
• Manufacturer (Section D): ACCU-LINE PRODUCTS INC.; 379 iyanough road; hyannis MA 02601
• Manufacturer (Section G): AVID MEDICAL; 9000 westmont drive; stonehouse commerce park; toano VA 23168
• Manufacturer Contact: nichole early ; 9000 westmont drive; stonehouse commerce park; toano, VA 23168 ; 8283387568
• MDR Report Key: 8595227
• MDR Text Key: 144600104
• Report Number: 1047429-2019-00007
• Device Sequence Number: 1
• Product Code: FZZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P-1RLNS
• Device Catalogue Number: P-1RLNS
• Device Lot Number: 80109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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