MAUDE Adverse Event Report: TELEFLEX MEDICAL DEROYAL SURGIMATE 35W 24/ CASE; SKIN STAPLER

Catalog Number 528435

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

Complaint alleges: "stapler worked half way thru surgery and would not fire anymore." no patient injury reported.Additional information was requested, but no additional information was submitted at the time of this report.

Manufacturer Narrative

Qn#(b)(4).A device history record (dhr) review could not be conducted since the lot number was not provided.No sample is available for the manufacturer to evaluate.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: DEROYAL SURGIMATE 35W 24/ CASE
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park; NC
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c. ; MX
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4605882
• MDR Text Key: 18002255
• Report Number: 3003898360-2015-00165
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 528435
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1