MAUDE Adverse Event Report: CONMED ELECTROSURGERY ULTRACLEAN 4" BLADE WITH EXTENDED INSULATION; ULTRACLEAN BLADE ELECTRODE

Catalog Number	139112EXT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received one (1) "unopened" packages containing the ultraclean 4" blade with extended insulation for evaluation.Visual examination of the returned package found partial seal disruption occurring in the final manufacturing seal.The device was transferred to packaging engineering for evaluation and testing.The device was confirmed that the seal failed the dye leak test on (b)(6) 2016.This open seal most probably was manufacturing operator error for there was a crease in the final manufacturing seal missed on inspection.This lot was manufactured on 25-jun-2015.A review of the device history record for this lot found no ncrs and no note of discrepancies during the manufacturing process.(b)(4).The reported packaging anomaly was obvious to the distributor and therefore prompted the return of the device 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.This device was manufactured prior to any corrective action implementation.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, one (1) package containing ultraclean 4" blade with extended insulation was discovered with "insufficient heat seal".The returned device exhibited partial seal disruption in the sterile barrier seal.In this instance, there was no patient involvement with this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.

• Brand Name: ULTRACLEAN 4" 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: 5703023
• Report Number: 3007305485-2016-00064
• Device Sequence Number: 250966
• Product Code: GEI
• UDI-Device Identifier: 10653405034773
• UDI-Public: (01)10653405034773(17)200623(30)50(10)201506254
• 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): 05/27/2016

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: Health Professional
• Device Expiration Date: 06/23/2020
• Device Catalogue Number: 139112EXT
• Device Lot Number: 201506254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1