MAUDE Adverse Event Report: CONMED CORPORATION VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WITH MEDIUM CERVICAL CUP; VCARE UTERINE MANIPULATOR

Catalog Number	60-6085-201
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received one (1) "unopened" package containing the vcare vaginal-cervical retractor-elevator with medium cervical cup for evaluation.The device was forwarded to package engineering for evaluation.Visual examination of the returned package found one (1) of the vendor seal sides of the pouch improperly sealed.The improper seal resulted in an inadequate seal that was unable to pass a dye leak test.It was confirmed that the sterile barrier had been breached.The vendor that the pouch was obtained from was requested a scar (supplier corrective action request).The lot was manufactured on 04-jan-2016.A review of the device history record for this lot found no ncrs and noted discrepancies during the manufacturing process.In this instance, preliminary investigation revealed that a probable cause of the inadequate seal may be the interaction between the device and the pouch.Of the lot containing (b)(4) units, there are no other similar complaints received.(b)(4).The packaging anomaly was obvious to the end-user facility and therefore prompted the return of the device for evaluation and replacement.The vendor who supplies the pouch was requested a scar by the supplier engineer.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 materials resource nurse reported that during review of incoming products, it was discovered there was an open seal on the pouch containing the vcare vaginal-cervical retractor-elevator with medium cervical cup.There was no patient involvement with this reported problem, as the open seal was discovered during inspection of product prior to clinical patient use.

• Brand Name: VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR WITH MEDIUM CERVICAL CUP
• Common Device Name: VCARE UTERINE MANIPULATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5708437
• Report Number: 1320894-2016-00066
• Device Sequence Number: 165740
• Product Code: LKF
• UDI-Device Identifier: 20653405082092
• UDI-Public: (01)20653405082092(17)180103(30)8(10)201601041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• 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: 01/03/2018
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201601041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1