MAUDE Adverse Event Report: TELEFLEX MEDICAL 24 EA ISI DA VINCI S 8MM OBTURATOR; LAPAROSCOPE, GENERAL & PLASTIC

Model Number	IPN028436
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Intuitive surgical detected failed sterile barrier at incoming inspection.The failed sterile barrier appears to be due to a poor heat seal.Intuitive surgical complaint number (b)(4).
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).Per dhr the product 24 ea isi da vinci s 8mm obturator lot # 73a2100003 was manufactured on 01/04/2021 a total of (b)(4) pieces.Lot was released on 01/19/2021.Dhr investigation did not show issues related to complaint.From the pictures attached it was confirmed the defect reported by the customer "incomplete seal - sterility compromised".However it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.A verification of failure mode reported in the current manufacturing process was conducted as follows: (b)(4) samples were taken from the current production p/n 420023 24 ea isi da vinci s 8mm obturator, lot # 73a2200754, the samples were visually inspected and issue reported " incomplete seal - sterility compromised" was not observed in the current manufacturing process.Revision of fmea-10-080 rev 03 was performed and the failure mode is already including it, no update is required.Failure mode "incomplete seal - sterility compromised" could be confirmed with picture attached, however it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.Failure mode "incomplete seal - sterility compromised" could be confirmed with picture attached.However it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.
Event or Problem Description
Intuitive surgical detected failed sterile barrier at incoming inspection.The failed sterile barrier appears (pictures) to be due to a poor heat seal.Intuitive surgical complaint number (b)(4).

• Brand Name: 24 EA ISI DA VINCI S 8MM OBTURATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC
• 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: 13500478
• Report Number: 3003898360-2022-00045
• Device Sequence Number: 5354471
• Product Code: GCJ
• UDI-Device Identifier: 14026704629586
• UDI-Public: 14026704629586
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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 Expiration Date: 01/04/2023
• Device Model Number: IPN028436
• Device Catalogue Number: 420023
• Device Lot Number: 73A2100003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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
• Patient Sex: Unknown