MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; GCJ

Model Number	C8XX2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: colon surgery.Medwatch received via mail on (b)(6) 2018: mw5078577: md was using a wound retractor for hand assisted colon surgery.The lower ring became detached from the upper ring inside of the patient's abdomen.All parts were removed from the patient.Received additional information via email on (b)(6) 2018 from regional risk management specialist at (b)(6): the event occurred at (b)(6).There was no harm to the patient.All pieces were able to be retrieved form the abdomen.I do have the device available for return.Patient status: no harm to patient.Type of intervention: unknown.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that complainant's experience of a detached inner ring.Engineering observed that the sheath was torn and was melted where the tear originated.Based on the condition of the returned unit, it is likely the reported event was caused by a hot instrument that made contact with the sheath, which caused the material to melt and a tear to form.This caused the inner ring to detach from the rest of the device.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.This report is to follow up medwatch report #5078577.
Event or Problem Description
Procedure performed: colon surgery.Medwatch received via mail on 07aug2018: mw5078577: md was using a wound retractor for hand assisted colon surgery.The lower ring became detached from the upper ring inside of the patient's abdomen.All parts were removed from the patient.Received additional information via email on 08aug2018 from regional risk management specialist: there was no harm to the patient.All pieces were able to be retrienved form the abdomen.I do have the device available for return.Patient status: no harm to patient.Type of intervention: unknown.

• Brand Name: C8XX2, GELPORT 120MM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7848875
• Report Number: 2027111-2018-00339
• Device Sequence Number: 1535698
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)200531(30)01(10)1323336
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: C8XX2
• Device Catalogue Number: 700025401
• Device Lot Number: 1323336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1