MAUDE Adverse Event Report: S & S SURGICAL SAFETY SCALPEL; HANDLE, SCALPEL

Model Number	D4511A
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: rough handling during transit.Corrective action: a change request has been submitted to add a "caution" notification label.Investigation summary: an internal complaint (call 47143) was received for a safety scalpel (part d4511a) that was not fully retracted into the handle, resulting in injuries to personnel unpacking the product.The defective device was not available for evaluation.However, photos of the reported failure were provided and confirmed the event.A device history record review was unable to be performed because the affected lot number was not provided.A check of finished good inventory found no loose or exposed blades.Because the locking mechanisms of the scalpels in finished good inventory were found to be functioning correctly prior to shipment, the scalpel vendor was not notified of the reported event.The reported failure of the blade being exposed was determined not to be a malfunction or defect of the scalpel.The investigation is complete at this time.If new or critical information is received, this report will be updated.
Event or Problem Description
Employees were cut from the scalpel blade when opening cases.Some blades were exposed and not locked.

• Brand Name: SAFETY SCALPEL
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): S & S SURGICAL; 117 edgington lane; wheeling WV 26003
• MDR Report Key: 8674520
• Report Number: 2320762-2019-00002
• Device Sequence Number: 19590619
• Product Code: GDZ
• UDI-Device Identifier: 50749756645381
• UDI-Public: 50749756645381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: D4511A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1