MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD PRECISOR BRONCHO DISPOSABLE BIOPSY FORCEPS ALLIGATOR CUP; FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number 100503

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

The customer complaint that the "jaws are getting stuck and they have had to use other tools to pry it open" is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported issue cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review found 3 complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 14 complaints, regarding 15 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.The ifu advises the user that : when advancing forceps through endoscope, care should be taken that, if resistance is met, the endoscope tip should be repositioned to allow smooth passage of the biopsy forceps.Be certain that the forceps are in the closed position prior to advancing the forceps into the endoscope, and maintain this closed position while moving through the working channel of the endoscope.Do not force the forceps if they do not pass smoothly through the endoscope, as this may damage both the forceps and the instrument channel of the endoscope.Do not apply excessive force when opening and closing the forceps.When removing the forceps, with the jaws closed, slowly withdraw the forceps from the endoscope.Be sure to lower the scope elevator before withdrawing the forceps from the scope.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported an issue involving precisor broncho disposable biopsy forceps alligator cup, item #100503.It was reported only the jaws are getting stuck and they have had to use other tools to pry it open.Additional information obtained 08may2019 provided lot m181220002 and indicates that the issue occurred during a bronchoscopy on (b)(6) 2019.It was reported that the doctor had advanced the forceps out into the lung.They took a bite of tissue and when he was pulling the forceps back through the scope the forceps got stuck.They were able to remove the forceps, (with the endoscope remaining intact in the patient) but once outside of the patient, the forceps were stuck closed.The doctor and nurse both tried to open the forceps.The doctor took a needle and forced the forceps open and retrieved the tissue.It was then noticed that there is sharp piece that is sticking out at the tip of the forceps.The procedure was successfully completed using another set of forceps with no impact or injury to the patient but with a delay, length unknown.No additional information was made available.This report is being raised on the basis of previous filings for injury and will be filed as a malfunction with the potential for injury.

• Brand Name: PRECISOR BRONCHO DISPOSABLE BIOPSY FORCEPS ALLIGATOR CUP
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD; no 10 gaoke third road; nanjing national h-tech zone; nanjing, 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH (NANJING) CO., LTD; no 10 gaoke third road; nanjing national h-tech zone; nanjing, 21003 2; CH 210032
• Manufacturer Contact: tracey weiselbenton ; 11311 concept blvd; largo, FL 33773-4908 ; 7273995557
• MDR Report Key: 8647932
• MDR Text Key: 175440191
• Report Number: 1320894-2019-00170
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 100503
• Device Lot Number: M181220002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1