MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CONMED REFLEX SKIN STAPLER

Catalog Number 8035

Device Problem Sticking (1597)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

The used device was returned to conmed quality assurance laboratory for evaluation.There were 23 staples remaining in the staple count indicator window.The 23 remaining staples fired and no staples jammed during or after firing, releasing from the device properly.This type of failure is reduced by in process testing for functionality and formation of the staples.The device was manufactured 24-mar-2014.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units, there has only been one similar complaint.A two (2) year review of product history for this device family revealed four (4) similar occurrences involving three (3) devices for staples not released after firing.During this same two (2) year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode 0.0001 percent.It should be noted, of the four (4) reports of staples not releasing after fired, there has been only one (1) report in which an incision was made to release the staple.To date there has been no patient long term adverse effects reported regarding any of the reported incidents.This failure mode is addressed in the risk document and the risk analysis shows an acceptable risk level.Device description: reflex one and reflex tl staplers are hand-held, disposable, sterile devices used to approximate open skin by deploying staples.Staplers contain a minimum of 35, 25, or 15 staples in wide and regular widths.Staples are comprised of 316l stainless steel and designed to hold skin in place until sufficient wound healing to allow for staple removal.A finger trigger is the staple deployment mechanism.Reflex one ejects the staple and as the trigger is released the next staple is loaded into position.Reflex tl continues to hold onto the staple at the end of the trigger stroke.The staple is not ejected until the trigger is released at which point the next staple is loaded.All product versions of the reflex staplers include a visible counter and provide audible and tactile feedback to confirm end of trigger stroke.The reflex one and reflex tl skin staplers are used for closure of skin in a wide variety of surgical procedures.Warnings: reflex one and reflex tl skin staplers should be used only by personnel with adequate training and knowledge of skin closure procedures.Reflex one and reflex tl are intended for use in skin closure procedures and are not to be used on internal tissue closures as placement and proximity to bones, vessels and internal organs are not verifiable.Prior to inserting staple.Confirm staple will be positioned free of other staples or obstructions.Firing a staple over another staple may result in tissue compression and risk of compromised healing or scarring.Precautions: always ensure trigger is fully closed and released to properly feed the next staple into position.

Event Description

As reported by the facility, during surgery, a staple from a conmed reflex skin stapler 8035, became stuck and didn't come out.In order to remove the staple, an extra incision was required which made the patient fell ill.There was no patient injury reported.

• Brand Name: CONMED REFLEX SKIN STAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 11 36; MX CP 1136
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: vickie ingle ; 525 french rd; utica, NY 13502 ; 3156243053
• MDR Report Key: 5833096
• MDR Text Key: 51371481
• Report Number: 3007305485-2016-00081
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMANDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/24/2019
• Device Catalogue Number: 8035
• Device Lot Number: 1403244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other