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 (pictures) 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 5,194 pieces.Lot was released on 01/19/2021.Dhr investigation did not show issues related to complaint.The customer returned one unit 420023 24 ea isi da vinci s 8mm obturator for investigation.The sample was returned with in its original packaging.The sample was examined with and without magnification.Upon visual examination, the packaging was split open.The sterile barrier appeared to be completely intact.However, there was a long crease on the package near the edge, just inside the sterile barrier.The packaging was split open along the crease.The root cause of this complaint is undetermined, but a non-conformance has been opened to further investigate this issue.The complaint is confirmed as the packaging was returned split open.Although the root cause could not be determined, a non-conformance has been opened to further investigate this issue.The reported complaint of "incomplete seal - sterility compromised" was confirmed based upon the sample received.The sample was returned with its packaging split open.The sterile barrier appeared to be completely intact.However, there was a long crease on the package near the edge, just inside the sterile barrier.The packaging was split open along the crease.The root cause of this complaint is undetermined, but a non-conformance has been opened to further investigate this issue.
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: 13500383
• Report Number: 3003898360-2022-00041
• Device Sequence Number: 20159462
• 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?: Device Returned to Manufacturer
• 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: 03/25/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown