MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; SKIN STAPLER

Catalog Number 528235

Device Problems Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

Complaint alleges: the customer reported that during a surgery the stapler did not work.The staples were stuck in the stapler.No patient injury reported.Additional information was requested, but no additional information has been submitted at the time of this report.

Manufacturer Narrative

(b)(4).Device history record (dhr) investigation did not show issues related to this complaint.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.

Manufacturer Narrative

(b)(4).One (1) stapler from catalog number 528235 visistat 35w (b)(4) was received used, opened without original package, lot # was not confirmed; stapler was received with remaining staples.During visual inspection it was observed that components looked well assembled.Functional inspection: stapler was fired for full activation cycle according to the ifu product "the trigger must be squeezed all the way in." after the staples were loaded, they formed & released properly.No quality issues were found.Although , from the sample received the defect reported by the customer stuck in stapler during visual inspection was observed, the root cause for this issue is considered unknown since the trigger components were received pre-activated & it is unknown why there was no complete cycle of activation.A functional inspection was and no quality issues were found.Therefore, a corrective action is not required at this time.In addition, all products are 100% tested by manufacturing and this defect would have been detected during the functional testing.

Event Description

Complaint alleges: the customer reported that during a surgery the stapler did not work.The staples were stuck in the stapler.No patient injury reported.Additional information was requested, but no additional information has been submitted at the time of this report.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4834398
• MDR Text Key: 17218221
• Report Number: 3003898360-2015-00387
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 528235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1