MAUDE Adverse Event Report: CONMED CORPORATION GOLDLINE ROCKER HOLSTER ULTRACLEAN; DISPOSABLE PENCIL

Catalog Number	131307A
Health Effect - Clinical Codes	No Patient Involvement (2645); Not Applicable (3189)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor in (b)(6) reported that during receiving and inspection of incoming products, 5 packages containing goldline rocker, holster, and ultraclean was discovered with "insufficient heat seal." 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.These devices were manufactured 18-may-2016.Of the lot containing (b)(4) units, there were no other similar complaints received for this item and lot number combination.A review of the device history record for this lot has verified that the devices were produced according to their current and approved procedures and material specifications.Any non-conformances regarding the product's identity, quality, safety and effectiveness were not identified during manufacture.A 2-year review of product history for this device family revealed 6 complaints involving 11 devices for this similar occurrence "insufficient heat seal." during this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure (b)(4) percent.As of this filing, the device has not been received.Once received, the evaluation will be completed and a supplemental and final will be filed.
Additional Manufacturer Narrative
Five (5) packages containing goldline rocker, holster, ultraclean electrodes were returned to conmed and evaluated by packaging engineering for "insufficient heatseal with pouch or blister pack." the packaging lab results showed that device one (1) failed the visual inspection, having less than 1/4" seal width due to misaligned material.The remaining four (4) devices passed the visual test and all five (5) devices passed the dye leak testing with no sterility breach detected.This failure mode is addressed in the risk document and the safety risk has been found to be acceptable.To date, there have been no serious injuries or deaths related to this reported problem however, a corrective action preventative action has been initiated to address this issue.

• Brand Name: GOLDLINE ROCKER HOLSTER ULTRACLEAN
• Common Device Name: DISPOSABLE PENCIL
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6093634
• Report Number: 3007305485-2016-00138
• Device Sequence Number: 1360307
• Product Code: GEI
• UDI-Device Identifier: 00653405056631
• UDI-Public: (01)00653405056631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• 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,Followup
• Report Date (Section B): 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: 131307A
• Device Lot Number: 201605185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other