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

Model Number	IPN028494
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the charger of the stapler is blocked.The issue occurred at the start of the procedure; it was not pretested.Recurring problem.No injury was reported.
Additional Manufacturer Narrative
(b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.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: 13 staplers were taken from the current production from p/n 528335 deroyal surgimate 35r 24/ case lot# 73m2200360 the staplers were functionally inspected and issue reported misfire/jamming - other was not observed in the current manufacturing process, the staples were loaded and released correctly.The device history review for the product visistat 35w non-sterile lot# 73h2100464 investigation did not show issues related to the complaint.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 since the sample is not available it is not possible to determine the source of the defect reported.The customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that the charger of the stapler is blocked.The issue occurred at the start of the procedure; it was not pretested.Recurring problem.No injury was reported.

• Brand Name: VISISTAT 35W NON-STERILE
• Common Device Name: STAPLE, REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15865126
• Report Number: 3003898360-2022-00759
• Device Sequence Number: 6909580
• Product Code: QQS
• UDI-Device Identifier: 34026704631798
• UDI-Public: 34026704631798
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN028494
• Device Catalogue Number: 528236
• Device Lot Number: 73H2100464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 11/25/2022
• Supplement Report FDA Received Date: 01/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown