MAUDE Adverse Event Report: MODERN MED EQUIPMENT MFG, LTD. SKIN STAPLER 35W; DISPOSABLE SKIN STAPLER

Catalog Number 25-3001C

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/30/2013

Event Type  malfunction  

Event Description

Different staff members complaining that the stapler's trigger is very hard to eject the staples and the staples are not closing.This is causing to pull additional staplers to complete the procedure.

Manufacturer Narrative

Investigation findings: the (b)(4) is supplied to deroyal by modern medical.The vendor was identified by the processing center qc.(b)(4) was issued to modern medical in reference to the report on (b)(6) 2013.Additional follow-ups were performed on (b)(6) 2013 and (b)(6) 2013.The response was received on (b)(6) 2013.The actual sample was not returned to deroyal for evaluation.Therefore, during the vendor investigation, the retention samples were evaluated and found to be working properly.The qfi report was reviewed as well as the 2012 and 2013 sales.Similar complaint information was obtained.Deroyal has sold (b)(4) cases of finished good (b)(4) and one similar report was identified in 2011.Correction: as per the customer's request, a replacement has been shipped on order# (b)(4).Root cause analysis: (b)(4): we suspected the staplers were not aligned in proper manner due to external impact.Therefore, the stapler was not pushed out from the cartridge in the right position, which caused incomplete forming.We believe this is an isolated case.Corrective and/or systemic correction action taken: (b)(4): we examined our retained samples (5pcs) to verify any failure possibilities; however, they were all performing well.Based on the failure mode and symptom, we had already done the necessary precautions on the packaging method.No additional actions were taken.Preventive action: scar (b)(4): a preventive action has not been taken.This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides information which changes the content of this report.

• Brand Name: SKIN STAPLER 35W
• Type of Device: DISPOSABLE SKIN STAPLER
• Manufacturer (Section D): MODERN MED EQUIPMENT MFG, LTD.; heng li, dongguan; guangdon 5234 66; CH 523466
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4752218
• MDR Text Key: 5772504
• Report Number: 1060680-2015-00025
• Device Sequence Number: 1
• Product Code: GDT
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-3001C
• Device Lot Number: 130303038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2013
• Event Location: Hospital
• Date Manufacturer Received: 07/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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