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	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.This report is to follow-up medwatch # (b)(4).
Event or Problem Description
Procedure performed: resection left colon - laparoscopic.Event description: complaint based on medwatch report # (b)(4).Medwatch received on 22-nov-2021 via mail."gelport was being used by the physician for the surgical procedure.Surgeon noted that gas was escaping the abdomen, but it was not apparent where the gas was leaking.Upon further investigation, it was noted that there was tear in the device causing the gas to leak and deflating the abdomen.The gelport was removed from the surgical field and replaced.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction- that is, the device did not do what it was supposed to do." product available for return as indicated in the mw report.Additional information was received via email on 09-dec-2021 from [name] hospital could not find the device, product no longer returning.Type of intervention: the case was completed with the new one.Patient status: no patient injury or illness was reported within the description of the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch #(b)(4).
Event or Problem Description
Procedure performed: resection left colon - laparoscopic.Event description: complaint based on medwatch report #(b)(4).Medwatch received on 22nov2021 via mail."gelport was being used by the physician for the surgical procedure.Surgeon noted that gas was escaping the abdomen, but it was not apparent where the gas was leaking.Upon further investigation, it was noted that there was tear in the device causing the gas to leak and deflating the abdomen.The gelport was removed from the surgical field and replaced.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction- that is, the device did not do what it was supposed to do".Product available for return as indicated in the mw report.Additional information was received via email on 09dec2021 from [name] hospital could not find the device, product no longer returning.Type of intervention: the case was completed with the new one.Patient status: no patient injury or illness was reported within the description of the complaint event.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13019279
• Report Number: 2027111-2021-00777
• Device Sequence Number: 5127425
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)240229(30)01(10)1431422
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 02/29/2024
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1431422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 85 KG