MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R37
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	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of seal component separation, as the shield, a clear plastic internal component of the seal, had detached from the seal.Based on the description of the event, it is likely that the reported event was caused by an asymmetrical instrument being inserted or removed through the seal in a non-axial manner.The instructions for use states, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".
Event or Problem Description
Procedure performed: gastric band.Event description: complaint 1 o f 2: (b)(4).Complaint 2 of 2: (b)(4).Information received from applied medical representative via phone 15may23: during bariatric surgery procedure a component (septum) of the seal fell inside the patient during insertion of the gastric band.This is the second time that this type of incident occurred.First occurrence of this event has not been declared by the hospital.Information received from product complaint form (b)(6) 2023: during bariatric surgery procedure a component (septum) of the seal fell inside the patient during insertion of the gastric band.No clinical impact on the patient as a result of the event.Another trocar applied was used to resolve the situation.Information received from applied medical representative via email 17may23: all pieces of the septum retrieved from the patient.I think the part was torn off.The surgeon passed a gastric band at the time of the incident.Grasping forceps were used prior to the incident.The part was the septum.No internal seal components were removed or cut in order to inspect the damaged component.The same model trocar was used to resolve the situation.Information received from applied medical representative via email 22may23: the patient is fine.Type of intervention: another trocar applied (c0r47).Patient status: the patient is fine.

• Brand Name: C0R37, 15X100 KII OPT ZTHR 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17384672
• Report Number: 2027111-2023-00530
• Device Sequence Number: 12282707
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)250529(30)01(10)1453600
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060096
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 05/29/2025
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1453600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GASTRIC BAND
• Patient Sex: Unknown