MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R39,KII 15X150MM Z-THR OPT SEP SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R39
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	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: sleeve gastretomy.Event description: doctor [name] found it has leakage problem after he pulling out the cannula from trocar, followed by inserting 5 mm instrument and then he discovered a part of the sleeve (black one) and the whole transparent sleeve were in patient abdominal.He took out the 2 falling parts and let the nurse to resemble it, no extra fragments were found in abdominal.Product return expected.Additional information received via email on 08aug2021 from user facility: a 5mm grasper was used through the trocar.Type of intervention: he used another trocar of c0r39 (same lot, new one) afterward without defect this time.Patient status: procedures went on after changing for another trocar.
Event or Problem Description
Procedure performed: sleeve gastretomy event description: doctor [name] found it has leakage problem after he pulling out the cannula from trocar, followed by inserting 5 mm instrument and then he discovered a part of the sleeve (black one) and the whole transparent sleeve were in patient abdominal.He took out the 2 falling parts and let the nurse to resemble it, no extra fragments were found in abdominal.Product return expected.Additional information received via email on 08aug2021 from user facility: a 5mm grasper was used through the trocar.Type of intervention: he used another trocar of c0r39(same lot, new one) afterward without defect this time.Patient status: procedures went on after changing for another trocar.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment.Visual inspection of the event unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.The fragmented septum confirmed the complainant¿s experience of seal leakage.Based on the condition of the returned unit, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states that, "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." septum fragmentation and seal leakage is not considered to be reportable as they are unlikely to cause or contribute to death or serious injury.The event is reportable due to the shield that had dislodged from the returned unit correction in g2: removed literature as a report source.

• Brand Name: C0R39,KII 15X150MM Z-THR OPT SEP SYS 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12316641
• Report Number: 2027111-2021-00602
• Device Sequence Number: 19628517
• Product Code: GCJ
• UDI-Device Identifier: 00607915116446
• UDI-Public: (01)00607915116446(17)240208(30)01(10)1406389
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,l
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 02/08/2024
• Device Model Number: C0R39
• Device Catalogue Number: 101415901
• Device Lot Number: 1406389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM GRASPER.