MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT PENCIL, TO, STANDARD 1" BLADE 10', HOLSTER, NC; ABC HANDPIECES OPEN

Catalog Number 130321

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint is unconfirmed.Received one 130321 in opened unoriginal packaging.Lot number could not be verified.Performed a visual inspection of the device, there were no obvious signs of abnormalities or defects.Performed a functional analysis, when the electrode blade was properly seated it fit as it should and did not "fall/slide" out.All dimensions were measured with digital calipers (c2251) and were within spec.A review of the dhr could not be performed since a lot number was not provided.A two-year lot history review could not be performed since a lot number was not provided.A two-year review of complaint history revealed there has been 2 complaints regarding 2 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; these devices should be inspected before use and discarded if damaged.Visually examine the devices for the following: cracked, broken or otherwise distorted plastics parts; damaged including cuts, punctures, nicks, abrasions, unusual lumps, and significant discoloration.Verify that the electrode is fully seated in the handpiece before use.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of the facility that the 130321, abc pencil's blade, fell out of the hand piece and into the patient's abdomen during an exploratory laparotomy on (b)(6) 2019.The tip was recovered immediately.The procedure was completed using another (same type) hand piece.There was no user or patient injury or impact reported.No surgical delay was reported.This report is being raised on the basis of device malfunction with potential for injury.

• Brand Name: PENCIL, TO, STANDARD 1" BLADE 10', HOLSTER, NC
• Type of Device: ABC HANDPIECES OPEN
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8708251
• MDR Text Key: 206363276
• Report Number: 3007305485-2019-00184
• Device Sequence Number: 1
• Product Code: HAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 130321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1