MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE, REMOVABLE (SKIN)

Model Number IPN028493

Device Problems Failure to Form Staple (2579); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visisat 35w 6/box lot#73g1900860 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that on two devices two different issues were noted: the first staples were malformed and the following staples stuck in the stapler.

Event Description

It was reported that on two devices two different issues were noted: the first staples were malformed and the following staples stuck in the stapler.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.Half of a broken clip and one closed, intact clip were also returned loose.The cartridge was visually examined with and without magnification.The cartridge contained 3.5 clips remaining in it, all broken.The broken loose clip was the pierced boss half of the clip.The clip had a staggered break at the hinge (inner hinge broken on pierced side and outer hinge broken in half).The hook half of the clip was not returned.All of the broken clips in the cartridge were broken in half at the hinge.The half clip in the cartridge was the pierced boss side of the clip.The hook side half was not returned.The clips breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The ifu for this product, 220002422, was reviewed as a part of this complaint investigation.The ifu states the following: "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge.Gently press the applier over the clip until there is an audible click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily." "remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.It may be necessary to hold the cartridge to allow the clip to be removed." "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." multiple clips were returned broken at the hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.One cartridge was returned.The cartridge contained 3.5 clips remaining in it, all broken.Half of a broken clip and one closed, intact clip were also returned loose.The broken loose clip was the pierced boss half of the clip.The clip had a staggered break at the hinge (inner hinge broken on pierced side and outer hinge broken in half).The hook half of the clip was not returned.All of the broken clips in the cartridge were broken in half at the hinge.The half clip in the cartridge was the pierced boss side of the clip.The hook side half was not returned.The clips breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10461471
• MDR Text Key: 205570849
• Report Number: 3003898360-2020-00670
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028493
• Device Catalogue Number: 528235
• Device Lot Number: 73G1900860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1