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

Model Number	C8XX2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: hand assist laparoscopic left hemicolectomy alexis wound protector was torn during procedure when surgeons hand was inserted in the gelport.When surgeon removed hand, alexis was also removed from patient and green ring was attached to upper retraction ring with small strip of clear plastic material.I have asked customer to retain product.Happened approximately one hour after procedure began.Additional information received via phone on (b)(6) 2018 from account manager: no patient injury.When hand was through gel, noticed a loss of pneumo.Gelport and alexis removed and green ring of alexis was dangling by one strip of plastic.Placed new gelport and completed case.Type of intervention: placed new gelport and completed case.Patient status: no patient injury.
Event or Problem Description
Procedure performed: hand assist laparoscopic left hemicolectomy alexis wound protector was torn during procedure when surgeons hand was inserted in the gelport.When surgeon removed hand, alexis was also removed from patient and green ring was attached to upper retration ring with small strip of clear plastic material.I have asked customer to retain product.Happened approximately one hour after procedure began.Additional information received via phone on (b)(6) 2018 from account manager: no patient injury.When hand was through gel, noticed a loss of pneumo.Gelport and alexis removed and green ring of alexis was dangling by one strip of plastic.Placed new gelport and completed case.Type of intervention: placed new gelport and completed case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear originating from a puncture in the sheath.Based on the condition of the returned unit, it is likely the reported event was caused by the instrumentation used during the procedure.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.

• 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: 7954587
• Report Number: 2027111-2018-00384
• Device Sequence Number: 19130164
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)200731(30)01(10)1327077
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/04/2019

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: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: C8XX2
• Device Catalogue Number: 700025401
• Device Lot Number: 1327077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1