MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the sheath had separated from the inner ring.Based on the condition of the returned unit, it is possible that the sheath delaminated due to a weak or incomplete heat seal between the sheath and the inner ring.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This a combined initial and follow-up report.
Event or Problem Description
Detailed description of event: hospital: [name]."after a few minutes, the air leakage occurred from this device because the wound sheath is incomplete attached the green ring.Please consult with photo." product return expected.Additional information received via email on 08jun2021 from [name]: the surgical staff did not notice the white ring break shown in the picture.The problem the surgeon encountered was that they could not establish pneumoperitoneum in surgery.No instruments were used through the device.A new device was used to complete the surgery.Patient status: "fine." type of intervention: a new device was used to complete the surgery.

• Brand Name: C8XX2, GELPORT 120MM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12285284
• Report Number: 2027111-2021-00596
• Device Sequence Number: 3751402
• Product Code: GCJ
• UDI-Device Identifier: 00607915118303
• UDI-Public: (01)00607915118303(17)220831(30)01(10)1391319
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1391319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1