MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES SC8XX2, GELPORT 120MM; GCJ

Model Number	SC8XX2
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.This report is the follow up report for medwatch report # 2600320000-2018-8124.
Event or Problem Description
Procedure performed: laparoscopic low anterior colon resection with handsewn colonal anastomosis.Event description: while using the gelport laparoscopic system the physicians noticed that the pneumo was not staying at the level that is should be and kept dropping making it difficult to operate.They started looking at instruments and ports to determine if there was a leak somewhere and it was at this time that they noticed that the gelport has a hole in it and was causing them to lose pneumo.The gelport with the hole in it was removed and replaced with a new gelport that was functioning properly and continued the surgery without further incident.Date of event: (b)(6) 2018.Additional information received via email on 16nov2018 from hospital project coordinator: "there was no harm to patient.The event date was (b)(6) 2018.It is unknown if trocars were placed through the gelport.It is unknown if instruments were placed directly through the gelpor".Patient status: no patient injury or illness occur associated with the complaint event.No harm to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the gel had separated from the ring.Based on the condition of the returned unit, it is likely the reported event was caused by minor inadequate manufacturing of the gel which was further propagated into significant gel separation during use, which caused the leakage.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 the follow up report for medwatch report # 2600320000-2018-8124 received from the fda via mail on 15nov2018.
Event or Problem Description
Procedure performed: laparoscopic low anterior colon resection with handsewn colonal anastomosis event description: medwatch report # 2600320000-2018-8124 received from the fda via mail on (b)(6) 2018.While using the gelport laparoscopic system the physicians noticed that the pneumo was not staying at the level that is should be and kept dropping making it difficult to operate.They started looking at instruments and ports to determine if there was a leak somewhere and it was at this time that they noticed that the gelport has a hole in it and was causing them to lose pneumo.The gelport with the hole in it was removed and replaced with a new gelport that was functioning properly and continued the surgery without further incident.Date of event: (b)(6) 2018.Additional information received via email on (b)(6) 2018 from hospital project coordinator: "there was no harm to patient.The event date was (b)(6) 2018.It is unknown if trocars were placed through the gelport.It is unknown if instruments were placed directly through the gelport." patient status: no patient injury or illness occur associated with the complaint event.No harm to patient.

• Brand Name: SC8XX2, GELPORT 120MM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8115485
• Report Number: 2027111-2018-00445
• Device Sequence Number: 16586972
• Product Code: GCJ
• UDI-Device Identifier: 00607915118303
• UDI-Public: (01)00607915118303(17)210614(30)01(10)1329242
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 06/14/2021
• Device Model Number: SC8XX2
• Device Catalogue Number: 100924402
• Device Lot Number: 1329242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/26/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR