MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; VIZISHOT 2 FLEX

Model Number NA-U403SX-4019

Device Problems Material Puncture/Hole (1504); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

One single use aspiration needle, vizishot 2 flex, model na-u403sx-4019, lot number fr837490 was returned to the service center for evaluation.The device was received in a poly bag and not the original device packaging.Upon visual inspection of the returned device it was observed that the pebax layer was damaged, approximately one inch from the distal tip of the spiral cut needle.The damage was observed to be on the same side as needle and the pointed needle tip.When fully retracted, the damage is proximal to the laser cut hypotube (lch).It was observed there was no damage to the spiral cut needle, lch or outer sheath during visual inspection.The distal edge of the pebax layer was intact and was observed to be in good condition.The observation suggests that the damage originated internally to the outer sheath.Additionally, chatter marks and multiple tears in the pebax layer suggested the damage was progressive and was attributed to multiple passes of the needle.No additional abnormalities were noted in the evaluation.It was attempted to replicate the reported malfunction failure, in multiple orientations, and all were unsuccessful.The device history record (dhr) was reviewed and all records indicate that the product was manufactured without any nonconformance reports (ncrs), or deviations and that all manufacturing specifications met final release criteria for the (b)(4) units manufactured; under the same lot number for the same reported event.Based upon the evaluation of the returned condition device, it could not be determined the root cause for the reported malfunction.This reported event will be continued to be monitored for this product for trending activities.

Event Description

A report was received at the service center for two vizishot 2 flex aspiration needles (na-u403sx-4019), both from the same lot number fr837490, that malfunctioned during a procedure on one patient.This is for the second needle that malfunctioned during the unspecified procedure.It was reported that a 19g ebus needle was used to puncture a lymph node; when the needle was removed from the working channel and the specimen expelled on to a glass dish, little to none of the specimen came out of the needle tip.An observation was noted that a strange noise was made, and the specimen ¿flew out¿ of the sheath portion of the device and not the needle.It was not reported if the intended procedure was completed and the outcome of the patient.It was not reported the type and model number of the scope used during the procedure.This is report 2 of 2.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 9541151
• MDR Text Key: 199253947
• Report Number: 2951238-2020-00299
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U403SX-4019
• Device Lot Number: FR837490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• 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