MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W; 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 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device sample has been returned but the investigation report has not been submitted at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the stapler was jamming and not releasing the staples.The patient's condition was reported as fine.

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; trigger component was received with staple pre-activated in the tip of the cartridge, stapler was received with excess embedded residues in the cartridge.Functional inspection: stapler was fired for full activation cycle according to the ifu product "the trigger must be squeezed all the way in" and staple pre-activated in the tip of the cartridge was loaded, and closed, however staple is not easy to release.Although; from the sample received the defect was observed during visual inspection & first activation; the root cause for this issue is considered unknown since that the trigger components was received pre-activated & it is unknown why it did not complete the activation cycle.In addition, stapler was received with dry residues embedded.After the second activation staples were loaded, closed & released; the device worked properly.Therefore at this time no corrective actions will be taken.All products are 100% tested by manufacturing and this defect would have been detected during the functional testing.

Event Description

Alleged event: the stapler was jamming and not releasing the staples.The patient's condition was reported as fine.

• Brand Name: VISISTAT 35W
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5036364
• MDR Text Key: 24354328
• Report Number: 3003898360-2015-00611
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 528235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1