MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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: ni.Event description: complaint created based on medwatch received by maude search.Report number (b)(4)."gel port was in the incision on patient's abdomen.Doctor put his hand through the port and the film inside detached from the ring.Upon inspection, it does not appear any of the film from the port was missing." device not available for return.This is an anonymous complaint filed by an unknown reporter via maude.Thus, no further information can be obtained.Intervention: ni.Patient status: no patient injury or illness was reported within the description of the complaint event.
Event or Problem Description
Procedure performed: laprascopic assisted low anterior resection with loop illeostomy.Event description: complaint created based on medwatch received by maude search.Report number (b)(4)."gel port was in the incision on patient's abdomen.Doctor put his hand through the port and the film inside detached from the ring.Upon inspection, it does not appear any of the film from the port was missing." device not available for return.This is an anonymous complaint filed by an unknown reporter via maude.Thus, no further information can be obtained.Additional information was received via mail on 06jul2021 from medwatch form uf/importer report #(b)(4).Form confirms that device cannot be returned.Account was identified from medwatch form (account #1007184- hennepin county med ctr).Additional information was received via email on 12jul2021 from [name]: the case was completed without incident.The event occurred during extraction of the colon.Device was disposed of after the procedure.Patient safety coordinator unable to provide more details regarding how the "film inside detached from the ring," she is unable to specify which part became "detached." type of intervention: "case was completed without incident".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, an analysis of the event unit could not be performed, and engineering was unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Based on the event description, it is possible that the sheath had separated from the ring due to a weak or incomplete heat seal.However, this could not be confirmed as the event unit was not returned.This report is to follow-up medwatch #(b)(4).Corrections: e1 - reporter name.

• 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: 12088725
• Report Number: 2027111-2021-00554
• Device Sequence Number: 4250473
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)220228(30)01(10)1377546
• 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,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 02/28/2022
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1377546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM HASSAN PORT; 30-DEGREE CAMERA; 5MM TROCAR
• Patient Age: 45 YR
• Patient Weight: 67