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	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: lap nephrectomy.Detailed description of event: the plastic portion of that connects the top to the bottom disconnected.Opened another gelport to continue the case.It is unknown at what point in the case the disconnection occurred.There was no patient injury.Photos to be provided the device is available for return.Patient status: no patient injury.Type of intervention opened a new gelport and continued the case.
Event or Problem Description
Name of procedure being performed: lap nephrectomy detailed description of event: the plastic portion of that connects the top to the bottom disconnected.Opened another gelport to continue the case.It is unknown at what point in the case the disconnection occurred.There was no patient injury.Photos to be provided.The device is available for return.Patient status: no patient injury type of intervention opened a new gelport and continued the case.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had separated from the inner ring.Based on the condition of the returned unit, it is likely the reported event was caused by 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.

• 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: 11369322
• Report Number: 2027111-2021-00342
• Device Sequence Number: 858789
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)220831(30)01(10)1395158
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 1395158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1