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 Insufficient Information (4580)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Use of the stapler to fix the skin at the end of the operation but the staples do not hold well to the skin and come off at the slightest contact with the scar.Clinical consequences: unknown at this time.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4) per dhr the product visistat 35w non-sterile lot # 73b2100291 was manufactured on 02/09/2021 a total of (b)(6) pieces.Lot was released on 02/19/2021.Dhr investigation did not show issues related to complaint.P/n (b)(4) 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: 13 staplers were taken from the current production from p/n (b)(4) visistat 35w 6/box lot# 73d2200410 the staplers were functionally inspected and issue reported "failure to function - staple re-opens" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028 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.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

Use of the stapler to fix the skin at the end of the operation but the staples do not hold well to the skin and come off at the slightest contact with the scar.Clinical consequences: unknown at this time.

• 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: 14187213
• MDR Text Key: 295423478
• Report Number: 3003898360-2022-00158
• Device Sequence Number: 1
• Product Code: GDT
• UDI-Device Identifier: 34026704631798
• UDI-Public: 34026704631798
• 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
• Report Date: 04/19/2022

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: 73B2100291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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