MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. RETRACTABLE SAFETY SCALPEL; HANDLE, SCALPEL

Catalog Number D4511A

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Root cause analysis: the reported issue has been determined to be a random event.The defective scalpel was not returned for evaluation.It is unknown whether the issue occurred due to pre-activation of the scalpel blade.Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (call (b)(4)) was received indicating that an employee was stuck in the finger by a scalpel blade (part number (b)(4)) upon attempting to remove the device from the packaging.A sample of the defective device was not returned to deroyal for evaluation.The quality control complaint specialist reviewed the routing instructions for part number (b)(4) about the device packaging.The routing instructions state the following: "assure the blade is completely retracted prior to packaging.Place 100 each scalpels in a double polybag.Make sure the scalpels are all turned in the same direction.Twist tie and poly liners shall be closed as firmly around scalpels as possible.Place two polybags with 100 each scalpels in the shipper case with sharp end toward each end of the box.Place one each insert per case.Place outer carton label on outer box." by packaging the product in the above mentioned manner, the devices can be removed from the shipping case with the blades facing away from the end user.(b)(4).Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.Device not returned to manufacturer.

Event Description

Cardinal personnel was ready to open a bag containing part (b)(4).The employee was stuck in the finger by a blade that was sticking out of the bag.

• Brand Name: RETRACTABLE SAFETY SCALPEL
• Type of Device: HANDLE, SCALPEL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 7, autopista joaquin balagu; pisano free zone, building 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 7, autopista joaquin balagu; pisano free zone, building 18; santiago, ; DR
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5291116
• MDR Text Key: 33960344
• Report Number: 3004605321-2015-00017
• Device Sequence Number: 1
• Product Code: GDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: D4511A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• 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: Unknown
• Patient Sequence Number: 1