MAUDE Adverse Event Report: CONMED CORPORATION REFLEX SKIN STAPLER 35 WIDE

Catalog Number	8535
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) 8535 reflex one skin stapler was returned for evaluation of "poor sealing." the upper left corner of the packaging tray, opposite the chevron seal was slightly deformed and there was a lack of adhesive transfer in this area.The packaging lab testing results show the device failed the visual inspection and dye leak test, and the seal width was less than 1/4 inch in the corner of the blister tray, thus the complaint is confirmed.The device was manufactured 1-march-2016.A review of the device history record for this lot found no noted discrepancies during the manufacturing process and no non-conformances regarding this product's identity, quality, safety, effectiveness or performance that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units there were no other similar complaints received.(b)(4).The reported packaging anomalies were obvious to the distributor and therefore prompted the return of the devices for evaluation and replacement.To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation, (b)(4), has been opened to address this issue.
Event or Problem Description
The distributor in (b)(4) reported that during receiving and inspection of incoming products, 1 package containing a reflex skin stapler 35 wide, was discovered to have "poor sealing." there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.This report is being filed based on the potential injury with recurrence.

• Brand Name: REFLEX SKIN STAPLER 35 WIDE
• Common Device Name: SKIN STAPLER
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6223014
• Report Number: 3007305485-2017-00001
• Device Sequence Number: 876918
• Product Code: GAG
• UDI-Device Identifier: 00653405036954
• UDI-Public: (01)00653405036954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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
• Operator of Device: No Information
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8535
• Device Lot Number: 201603015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1