MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W NON-STERILE; STAPLE, REMOVABLE (SKIN)

Model Number IPN914814

Device Problem Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

This is the first time we have had this problem.The failure was noticed during the intervention during its use.The sample is within our premises but it is contaminated.There were no consequences for the patient or the staff but it was necessary to use a new stapler so open a new custom pack kit.Additional information: the staples are twisted and do not function correctly.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product visistat 35w non-sterile lot # 73k2000540 was manufactured on 10/26/2020 a total of (b)(4) pieces.Lot was released on 11/06/2020.Dhr investigation did not show issues related to complaint.P/n 528236 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: (b)(4) staplers were taken from the current production from p/n 528135 visistat 35r 6/box lot# 73k2100876 the staplers were functionally inspected and issue reported "misfire/jam-staples not forming/closing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of (b)(4) rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

Event Description

This is the first time we have had this problem.The failure was noticed during the intervention during its use.The sample is within our premises but it is contaminated.There were no consequences for the patient or the staff but it was necessary to use a new stapler so open a new custom pack kit.Additional information: the staples are twisted and do not function correctly.

Manufacturer Narrative

(b)(4).The customer returned one unit 528236 visistat 35w non-sterile for investigation.The returned stapler was visually examined with and without magnification.Visual examination of the returned stapler revealed that the staples appeared properly aligned.The sample was returned with its trigger partially engaged and the first staple partially formed as a result.The stapler was received with 25 staples left in the cartridge indicating that at least 10 staples were fired by the end user.Functional inspection was performed by attempting to fire staples from the returned stapler.Using hand pressure, the trigger cycle was completed.Upon full completion of the trigger, the partially formed staple was able to form completely and release.This was repeated three more times with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.The remaining staples were all able to engage and close into the skin pad.No functional issues were found with the returned device.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." a corrective action is not required at this time as there were no functional issues found with the returned stapler.The reported complaint of "misfire/jam-staples not forming/closing" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.There were no functional issues found with the returned stapler.

Event Description

This is the first time we have had this problem.The failure was noticed during the intervention during its use.The sample is within our premises but it is contaminated.There were no consequences for the patient or the staff but it was necessary to use a new stapler so open a new custom pack kit.Additional information: the staples are twisted and do not function correctly.

• Brand Name: VISISTAT 35W NON-STERILE
• Type of Device: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12856202
• MDR Text Key: 281148288
• Report Number: 3003898360-2021-01043
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 14026704672896
• UDI-Public: 14026704672896
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

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 Model Number: IPN914814
• Device Catalogue Number: 528236
• Device Lot Number: 73K2000540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/05/2021; 03/10/2022
• Supplement Dates FDA Received: 12/17/2021; 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1