MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B7016, FORTE AXP SET 12/14/18F 35CM 6/BX; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	B7016
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
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 investigation.
Event or Problem Description
Procedure performed: laser for stones.Complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Event description: both these two axh sheath was used during a procedure.Outer piece spirrale.Kinked below.Additional information provided 15feb2022 via email from [name] non-conformance report: product kinked, broken, spiralled.Patient status: no patient injury.Type of intervention: ni.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of the sheath partially unraveling.Based on the condition of the returned unit, the reported event was most likely caused by contact with an instrument followed by a high force exerted on the unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: laser for stones.Complaint 1 of 2:(b)(4).Complaint 2 of 2: (b)(4)- mfr 2027111-2022-00468.Event description: both these two axh sheath was used during a procedure.1.Outer piece spirrale.2 kinked below.Additional information provided 15feb2022 via email from [name] non-conformance report: product kinked, broken, spiralled.Additional information received from distributor via email on 10-mar-2022: no pictures were taken before the devices were sent to the manufacturer.Both access sheaths kinked during removal and one spiralled off during the procedure, as you can see in the returned product.Two other access sheaths were used and worked perfectly.Patient status: no patient injury.Type of intervention: two other access sheaths were used and worked perfectly.

• Brand Name: B7016, FORTE AXP SET 12/14/18F 35CM 6/BX
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• 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: 13772627
• Report Number: 2027111-2022-00467
• Device Sequence Number: 17103080
• Product Code: FED
• UDI-Device Identifier: 00607915113148
• UDI-Public: (01)00607915113148(17)240616(30)01(10)1421510
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K993650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 06/16/2024
• Device Model Number: B7016
• Device Catalogue Number: 100794903
• Device Lot Number: 1421510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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 Sex: Unknown