MAUDE Adverse Event Report: CONMED CORPORATION FLOVAC SUCTION/IRRIGATION HANDPIECE WITH 10' TUBING, DUAL SPIKES; SUCTION IRRIGATOR HANDPIECE

Catalog Number	60-6005-505
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received one (1) "unopened" package containing the flovac suction/irrigation handpiece for evaluation.Visual examination of the returned package found there was a hole in the seal area of the packaging.The packaging engineer confirmed that there was adhesive transfer and the package was sealed at one point.It is possible the hole in packaging may be related to shipping and handling of the device.This lot was manufactured on 22-sep-2015.A review of the device history record for this lot found no ncrs and no note of discrepancies during the manufacturing process.Of the lot containing (b)(4) units, there are no other similar complaints received.A two (2) year review of product history for this device also showed no other similar complaints.(b)(4).The reported packaging damage was obvious to the end-user 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 initiated 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 end-user reported that during pre-op testing, a tear in the package of a flovac suction and irrigation handpiece was found.In this instance, there was no patient involvement with this reported device, as the packaging damage was discovered during clinical inspection with pre-op setup.

• Brand Name: FLOVAC SUCTION/IRRIGATION HANDPIECE WITH 10' TUBING, DUAL SPIKES
• Common Device Name: SUCTION IRRIGATOR HANDPIECE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6322558
• Report Number: 3007305485-2017-00025
• Device Sequence Number: 19006480
• Product Code: GCJ
• UDI-Device Identifier: 00653405034752
• UDI-Public: (01)00653405034752(17)180921(30)1(10)201509224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: 09/21/2018
• Device Catalogue Number: 60-6005-505
• Device Lot Number: 201509224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1