MAUDE Adverse Event Report: MEDLINE INDUSTRIES; BLADE,CARBON-STEEL,#11,STRL,DISPOSABLE

Catalog Number MDS15011

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that a surgeon noticed discoloration on the scalpel blade after being used.The discoloration was not noticed on the blade before use and the blade was not visually inspected prior to use.The blade was used to make the initial incision and used within the surgical site.No harm came to the patient.The sample was received for evaluation and the issue was confirmed.Due to the reported incident and in an abundance of caution this medwatch is being filed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after the initial incision, the blade was noticed to be discolored.

• Type of Device: BLADE,CARBON-STEEL,#11,STRL,DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 7072542
• MDR Text Key: 93820651
• Report Number: 1417592-2017-00077
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MDS15011
• Device Lot Number: 102782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• 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: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 94