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

Catalog Number 528235

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Alleged issue reported: the stapler got stuck and could not be used anymore.Patient's condition was reported as fine.

Event Description

Alleged issue reported: the stapler got stuck and could not be used anymore.Patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).No sample is available for the manufacturer to evaluate.The manufacturer will continue to monitor and trend relating complaints.

Manufacturer Narrative

(b)(4).One (1) stapler from catalog number 528235 visistat 35w 6/box was received used, opened without original packaging, lot # was not confirmed, and stapler was received with remaining staples.During visual evaluation it was observed that components looked well assembled, however traversed staple / staples over the load of staples, no stuck staples in the tip of the cartridge.Failure mode jamming was confirmed with sample received during visual evaluation.Failure mode jamming was confirmed with sample received during visual evaluation, however; functional evaluation could not be performed by the conditions of the sample.To improve the manufacturing process of the staple an engineering test request # (b)(4) was opened to reduce/mitigate or eliminate misalignment staples, stuck staples.The manufacturer will continue to monitor trending of similar complaints.

Manufacturer Narrative

(b)(4).Root cause conclusion: no conclusion code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

Alleged issue reported: the stapler got stuck and could not be used anymore.Patient's condition was reported as fine.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; kino # 1316,rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; kino # 1316,rancho el descanso; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4794867
• MDR Text Key: 5834016
• Report Number: 3003898360-2015-00399
• 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,Followup
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/18/2019
• Device Catalogue Number: 528235
• Device Lot Number: 73L1400335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1