MAUDE Adverse Event Report: CONMED CORPORATION REFLEX SKIN STAPLER

Catalog Number 8535

Device Problems Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Conmed corporation received one (1) unopened package containing the 8535 reflex skin stapler device for evaluation.Visual examination of the returned product noted "that the seal area on one side of the blister pack was improperly sealed.This could have been done by process variations.This device was transferred to the packaging engineering test lab for dye leak testing.The packaging failed dye leak testing, on 13-jul-2016, confirming there was a breach in the sterility of this device.An investigation has been initiated to evaluate this issue.This lot was manufactured on 18-jan-2016.A review of the device history record for this lot found no ncrs and no discrepancies noted during the manufacturing process.Of the (b)(4) units shipped to the distributor from this lot, this was the only unit found with an "insufficient heat seal" by the distributor's inspector.The distributor's inspector performs a 100% incoming inspection of all devices.There have been no other similar complaints received on this lot which contained a total of (b)(4) units.A two year review of product history for this device family showed (b)(4) previous complaints for (b)(4) devices with an "insufficient heat seal".(b)(4).Preliminary investigation revealed the most probable cause of the creases found in the seal is manufacturing related.The manufacturing supervisors have been made aware of this reported problem and an investigation has been requested.To date, there have been no serious injuries or death related to this reported problem.To prevent future recurrences, an investigation has been opened to address this issue.

Event Description

The distributor in (b)(4) reported that during receiving and inspection of incoming products, "insufficient heat seal" was found in the sealing area of a sterile package containing the 8535 reflex skin stapler device.There was no patient involvement with this reported device, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.

Manufacturer Narrative

This supplemental report corrects a minor discrepancy in information provided in the original medwatch.The corrections were identified during an internal retrospective review of medwatch reports filed for complaints received by conmed between 01/01/2015 and 02/15/2017.This review was performed in accordance with a pre-approved protocol, conmed document #(b)(4), which defined a process for performing and documenting reviews of previously submitted medwatch reports for accuracy and completeness.

• Brand Name: REFLEX SKIN STAPLER
• Type of Device: SKIN STAPLER
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 11 36; MX CP 1136
• Manufacturer Contact: vickie ingle ; 525 french rd; utica, NY 13502 ; 3156243053
• MDR Report Key: 5869171
• MDR Text Key: 52848551
• Report Number: 3007305485-2016-00079
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: 8535
• Device Lot Number: 201601184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1