MAUDE Adverse Event Report: DEROYAL INDUSTRIES SKIN STAPLE EXTRACTOR; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number TSR-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

(b)(6) med.Ctr.Just started using the skin staple removers and has concerns about employees getting stuck with the extracted staples.The main concern is that the staple gets stuck on the extractor and has to be pulled off manually.It does not fall off without assistance.

Manufacturer Narrative

Investigation findings: the qfi report was reviewed to obtain the sales and similar complaint information.Deroyal has sold (b)(4) cases of the finished good from 2013 to 2015.There have been no previous reports of this nature prior to the customer filing two complaints.Raw material (b)(4) lot number 1195857 was utilized within the finished good and lot number reported.The device in use during the reported incident was not returned.However, representative samples were received from the reporting customer and consisted of four each of the device sealed within the package.Lot number 36427356 was returned and not the lot number reported.Lot mapping was performed and it was identified that one of the raw material lot numbers utilized was the same as the reported lot number: 36427356, (b)(4), 1195857; 36427356, (b)(4), 1135466.The samples were functionally tested by removing staples from a box of foam.All of the skin staple removers performed as intended with no identifiable issues.A scar was issued to (b)(4)., the raw material supplier, with a due date of 04/20/2015.As of the date of this report, the scar has not been returned.The investigation is incomplete at this time.This report will be updated when new information becomes available.

• Brand Name: SKIN STAPLE EXTRACTOR
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1703 hwy. 33 south; new tazewell TN 37824
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4717909
• MDR Text Key: 19409014
• Report Number: 1060680-2015-00014
• Device Sequence Number: 1
• Product Code: KDD
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TSR-1
• Device Lot Number: 37840185
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/10/2015
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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