MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8XX2CE, GELPORT 120MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8XX2CE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
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
The event unit is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed.Miles procedure.[name] hospital: "after the patient setup was complete, the alexis sheath torn when the doctor inserted his hand into the gel seal cap then pulled it out.New package was opened and procedure was completed.This surgeon performs hals a lot and has been doing 10 cases in last 2 months." product available for return.Additional information was received via email on 19mar2021 from [name]: "i checked the information and i thought this issue has been occurred because the physician's hand contacted with the sheath and the sheath had an excessive load.Therefore, i think this issue is not a device related event.In any case, since there was no health damage to the patient and no information indicating the serious situation i decided i do not report this event to pmda." additional information was received via email on 22mar2021 from [name]: "the tear occurred near the green ring and no instruments were inserted into the gel." patient status: no patient injury.Type of intervention: case was completed with a new one.
Event or Problem Description
Name of procedure being performed miles procedure [name] hospital "after the patient setup was complete, the alexis sheath torn when the doctor inserted his hand into the gel seal cap then pulled it out.New package was opened and procedure was completed.This surgeon performs hals a lot and has been doing 10 cases in last 2 months." product available for return.Additional information was received via email on (b)(6) 2021 from [name]: "i checked the information and i thought this issue has been occurred because the physician's hand contacted with the sheath and the sheath had an excessive load.Therefore, i think this issue is not a device related event.In any case, since there was no health damage to the patient and no information indicating the serious situation i decided i do not report this event to pmda." additional information was received via email on (b)(6) 2021 from [name]: "the tear occurred near the green ring and no instruments were inserted into the gel." patient status: no patient injury.Type of intervention: case was completed with a new one.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering confirmed that the sheath of the returned unit had torn.Engineering also observed that a portion of the sheath had uneven cuts.Applied medical is unable to determine the root cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C8XX2CE, 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: 11653841
• Report Number: 2027111-2021-00444
• Device Sequence Number: 3697930
• Product Code: GCJ
• UDI-Device Identifier: 20607915123905
• UDI-Public: (01)20607915123905(17)230410(30)01(10)1392600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 04/10/2023
• Device Model Number: C8XX2CE
• Device Catalogue Number: 700314609
• Device Lot Number: 1392600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1