MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT LAP PROBE; ABC HANDPIECES- LAPAROSCOPIC

Catalog Number	160656
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported unused device was returned in its original unopened package for evaluation.Visual inspection by the packaging engineer identified a hole on the plastic side of the sterile pouch.This defect was most likely caused by the prongs of the device puncturing the plastic after the sealing process took place.This hole caused a breach in sterility.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, one complaint has been reported for this product and failure mode.A two-year review of complaint history revealed (b)(4) complaints involving (b)(4) devices have been reported.During this same time frame, (b)(4) devices have been sold worldwide.A risk analysis was performed and the risk was deemed acceptable.This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.The instructions for use (ifu) provides the following warning.If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately.This incident type will continue to be monitored through the complaint system.
Event or Problem Description
The distributor in (b)(6) reported a scratch on the packaging of a 160656 lap probe that was identified during incoming inspection.In this instance, there was no patient involvement as the packaging anomaly was discovered prior to distribution to an end-user.This rejection report was for (b)(6) 2017.Conmed received it and the decision to not report this cosmetic defect was made in (b)(6) 2017.The reported device was returned to conmed for evaluation and a breach in sterility was found.This report is raised on the basis of the sterile breach identified during the device evaluation.

• Brand Name: LAP PROBE
• Common Device Name: ABC HANDPIECES- LAPAROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua 31136 ; MX 31136
• MDR Report Key: 6884462
• Report Number: 3007305485-2017-00214
• Device Sequence Number: 1142220
• Product Code: GEI
• UDI-Device Identifier: 20653405003899
• UDI-Public: (01)20653405003899(17)210621(10)201606224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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: 06/21/2021
• Device Catalogue Number: 160656
• Device Lot Number: 201606224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1