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

Model Number	C8XX2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure performed: lap colectomy.The rep was not present during the case.During the case the surgeon was pulling on the alexis and it tore in two.Location of the damage is unknown.It is unknown if any instrumentation came in direct contact with the alexis.No patient injury.Product is available for return.Patient status: no patient injury.Type of intervention: ni.
Event or Problem Description
Name of procedure performed:lap colectomy.The rep was not present during the case.During the case the surgeon was pulling on the alexis and it tore in two.Location of the damage is unknown.It is unknown if any instrumentation came in direct contact with the alexis.No patient injury.Product is available for return.Additional information received via email on 18dec2020 from[name]: "i spoke with [name] today, he's decided that he does not want to send the device for evaluation based on admittance from or staff that the failure was due to the surgeon being rough with the device rather than device failure.".No product return.Additional information received via email on 05jan2020 from [name]: it is unknown what part of the alexis broke.The device was not in the patient when it broke.No pieces of the product fell into the patient.The case was completed by replacing the device.No photos are available.Patient status: no patient injury.Type of intervention: ni.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, the complainant's experience of a torn sheath could not be confirmed.Based on the additional information received from the complainant, it is likely that the torn event unit was caused by the excessive force exerted on the device by the user.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.The event unit was torn before the device was used in the patient.This report is to follow up medwatch report # 2027111-2020-00637.

• Brand Name: C8XX2, GELPORT 120MM
• Common Device Name: GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10942992
• Report Number: 2027111-2020-00637
• Device Sequence Number: 14213951
• Product Code: KGW
• UDI-Device Identifier: 20607915123912
• UDI-Public: (01)20607915123912(17)220831(30)01(10)1395159
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K014047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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: 08/31/2021
• Device Model Number: C8XX2
• Device Catalogue Number: 700314608
• Device Lot Number: 1395159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1