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 Failure to Cut (2587); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported device has been received by conmed and has entered into the evaluation process.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.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 involving precisor broncho disposable biopsy forceps alligator cup, item #100503, lot m181220002.It was reported that "today, the doctor used them in a procedure and again noted that they did not take a complete bite into the tissue.In fact, they did not close completely, tore a strip of tissue from the airway, and got stuck in the channel of the bronchoscope." additional information obtained indicates that the issue occurred during a bronchoscopy with biopsy procedure.There were no issues in inserting the forceps into the 2mm bronchoscope working channel.The issue was encountered after the sample was obtained and they attempted to pull the forceps with the sample back out of the bronchoscope.They had to remove the scope and cut the forceps since they wouldn't close completely.They cracked the lens of scope in doing so.The procedure was completed by using multiple precisor forceps and additional sedation and prolonged procedure was experienced.It is indicated that the patient had to go to icu (intensive care unit).The reason for the icu transfer was not made clear.Additional information received on 03april2019 indicates that the reporter was not able to obtain an update on the status of the patient.The tissue was considered torn as it was not as clean a cut or specimen as the surgeon wanted and considered not a quality sample.They did intend to take a sample of that tissue in the airway and the reported delay was about 15 minutes to the procedure.The reporter indicated there is no additional information available.This report is being raised on the basis of injury (patient going into the icu).

Manufacturer Narrative

The complaint is confirmed.Three 100503 were received in opened packaging, the reported catalog number was verified, the lot number was not verified.A visual inspection found that two of the devices were cut towards the distal end, one of the cut device also had the blue coating removed.Inspection found that the uncut device was unable to actuate (could not open or close and the handle was not moving).Due to the condition of the cut devices interaction between the handle and jaws could not be evaluated.Manually opening/closing the jaws by hand was not smooth and required a greater than expected amount of force.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 2 complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4)complaints, regarding (b)(4) 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 before using, ensure that the device is compatible in shape, length and size with the endoscope being used.It is advisable to have a spare, unopened grasping forceps available for the procedure.Open and close the jaws several times using the handle to confirm smooth movement.Do not use the forceps if it is damaged.It is noted: 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.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.

• 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, jiangsu 21003 2; CH 210032
• MDR Report Key: 8509203
• MDR Text Key: 141765312
• Report Number: 1320894-2019-00103
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 100503
• Device Lot Number: M181220002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other