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

Model Number C8XX2

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: left hand-assisted nephrectomy.Detailed description of event: during the case, the alexis sheath was first deployed within the incision.The gel cap was placed over the alexis and a 5mm [name] trocar was used through the cap for about 30 minutes.At that point the procedure was switched to open and the gel seal cap was removed.When the cap was removed, the sheath fell away from the ring and the alexis was no longer able to provide retraction at the incision site.The device did not fragment.The device was removed from the patient and a new alexis was opened to provide retraction and complete the case.No patient injury.The device is available for return.Additional information received via email on 03aug2020 from [name]: photos have been provided of the device packaging.Additional information received via email on 12aug2020 from [name]: "unfortunately, my contact [name] general service lead did not remember which ring the sheath separated from.The only picture that she took was the outside of the box same one that i provided to you with the lot number.I did confirm the inner ring was able to be pulled out of incision like it typically would.No patient harm and no fragmentation." patient status: no patient injury.Type of intervention: the device was removed from the patient and a new device was opened to provide retraction and complete the case.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had separated from the inner ring.Based on the condition of the returned unit, it is likely the reported event was caused by a weak or incomplete heat seal between the sheath and the inner ring.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure being performed: left hand-assisted nephrectomy.Detailed description of event: during the case, the alexis sheath was first deployed within the incision.The gel cap was placed over the alexis and a 5mm [name] trocar was used through the cap for about 30 minutes.At that point the procedure was switched to open and the gel seal cap was removed.When the cap was removed, the sheath fell away from the ring and the alexis was no longer able to provide retraction at the incision site.The device did not fragment.The device was removed from the patient and a new alexis was opened to provide retraction and complete the case.No patient injury.The device is available for return.Additional information received via email on 03aug2020 from [name] : photos have been provided of the device packaging.Additional information received via email on 12aug2020 from [name]: "unfortunately, my contact [name] general service lead did not remember which ring the sheath separated from.The only picture that she took was the outside of the box same one that i provided to you with the lot number.I did confirm the inner ring was able to be pulled out of incision like it typically would.No patient harm and no fragmentation." patient status: no patient injury.Type of intervention: the device was removed from the patient and a new device was opened to provide retraction and complete the case.

• Brand Name: C8XX2, GELPORT 120MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10420834
• MDR Text Key: 203486185
• Report Number: 2027111-2020-00530
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)211110(30)01(10)1384688
• Combination Product (y/n): N
• PMA/PMN Number: K014047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1384688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5MM COVIDIEN TROCAR