MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT REFLEX SKIN STAPLER, 35 WIDE; STAPLER, SURGICAL

Catalog Number 8535

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that 8535, reflex skin stapler, 35 wide, device was being used to close a scalp incision after a neurosurgical procedure on (b)(6) 2019.It is reported that "the tip part (upper plastic part) removed during use (after stapling)." further research with the reporter found that a component on the stapler came loose while the device was in use stapling the scalp.The component is not reported as having fallen into the incision; therefore, there was nothing to remove from the patient.There was no extended hospital stay or medical intervention required for this event.There was no reported injury to the user or the patient.The reported delay time for this event is "a few minutes" as it was necessary to use a new product.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

One 8535 was received in opened unoriginal packaging, the reported catalog numbers was verified, the lot number was not verified.Visual inspection found that the nose closure was missing.Inspection of the remaining device found that the plastic appeared to have broken near the weld area that the component would be attached.The most probable cause of this failure was that the weld on the nose was weak.To further investigate the testing of the weld the lot number would be required for a device history record review.The lot number is not available; therefore, further investigation of this probable cause cannot be conducted.A lot history review could not be performed due to no lot number being reported.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 1,438,914 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0000007.Per the instructions for use, the user is advised the following: contraindications: when it is not possible to maintain at least 5mm distance from the stapled skin to underlying bones, vessels and internal organs, the use of staples for skin closure is contraindicated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: REFLEX SKIN STAPLER, 35 WIDE
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 8351148
• MDR Text Key: 136619032
• Report Number: 3007305485-2019-00035
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1