MAUDE Adverse Event Report: CONMED ELECTROSURGERY ULTRACLEAN 6" COATED BLADE WITH EXTENDED INSULATION; ULTRACLEAN BLADE ELECTRODE

Catalog Number	139110EXT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received two (2) "unopened" packages containing the ultraclean 6" coated blade with extended insulation for evaluation.Visual examination of the returned products found the packaging with small creases in the sealing areas on the straight seal of the packages (seal opposite chevron seal).It appears that there may be small channels through each of the seals.The devices were transferred to packaging engineering test lab for dye leak testing and one device was confirmed as unsterile failing the dye leak test on (b)(6) 2016.The second device was confirmed for an intact sterile barrier.In this instance, preliminary investigation revealed that the most probable cause of the creases found in the seals is due to inadequate placement of the devices onto the bar sealer that is most likely related to operator error, or, the pouch packaging was damaged prior to sealing and was missed on inspection.An investigation has been opened in apr-2015 and the manufacturing supervisors have been made aware of this reported problem to identify and implement the necessary corrective actions to prevent future recurrences.This lot was manufactured on 05-may-2015.A review of the device history record for this lot found no ncrs and noted no discrepancies during the manufacturing process.Of the (b)(4) units from this lot shipped to the distributor, there were two (2) units found with "insufficient heat seals" by the distributor inspector, who performed 100% incoming inspection of all devices.In addition, of the overall lot containing (b)(4) units, there are no other similar complaints received.A two (2) year review of product history for this device family showed an additional (b)(4) complaints involving a total of (b)(4) devices reported for "insufficient heat seal".(b)(4).The 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 has been opened to address this issue.As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use).In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
Event or Problem Description
The distributor in (b)(4) reported that during receiving and inspection of incoming products, two (2) packages containing the ultraclean 6" coated blade with extended insulation were discovered with "insufficient heat seals".Both of the returned packages exhibited creases in the final manufacturing seals.In this instance, there was no patient involvement with this reported problem, as the packaging anomalies were discovered during inspection at the distributor facility prior to distribution to an end-user.

• Brand Name: ULTRACLEAN 6" COATED BLADE WITH EXTENDED INSULATION
• Common Device Name: ULTRACLEAN BLADE ELECTRODE
• Manufacturer (Section D): CONMED ELECTROSURGERY; 14603 east fremont avenue; centennial CO 80112
• MDR Report Key: 5679093
• Report Number: 3007305485-2016-00059
• Device Sequence Number: 307304
• Product Code: GEI
• UDI-Device Identifier: 20653405007347
• UDI-Public: (01)20653405007347(17)200503(30)50(10)201505054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2016

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: 05/03/2020
• Device Catalogue Number: 139110EXT
• Device Lot Number: 201505054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2016
• Initial Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1