MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R39,KII15X150MM Z-THR OPT SEP SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R39
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: lap gastric sleeve event description: during the case the specimen was about to be removed from the port site with a bag, the 15mm trocar was removed and the specimen was removed successfully.The surgeon then noticed a small black object on the screen.The surgeon then removed two objects from the peritoneum.The removed objects were compared to a new 15mm trocar to confirm it had come from the used c0r39.The surgeon was satisfied it has been removed from the patient and did not request an x-ray.Additional information received via email from applied team member on november 5, 2020: i spoke with the surgeon regarding this incident this morning.His incident report is attached.Further information as stated below is that ¿leaking¿ was heard on entry of an instrument.The port was inspected appeared ok but then in replacing the port and inserting the instrument the objects in the abdomen were seen.The instrument being used in the port was a [non-applied] black stapler.Incident report received via email from user facility on 05nov20: after i introduced an instrument through, the valve started leaking, i fully removed the part and could not see a problem, so replaced and continued to use the part.Two minutes later we saw two free pieces of the part lying in abdomen.We then pulled apart the part (pulled of black valve) and saw broken part internally.Patient status: patient is fine, no further action needed.
Event or Problem Description
Procedure performed: lap gastric sleeve.Event description: during the case the specimen was about to be removed from the port site with a bag, the 15mm trocar was removed and the specimen was removed successfully.The surgeon then noticed a small black object on the screen.The surgeon then removed two objects from the peritoneum.The removed objects were compared to a new 15mm trocar to confirm it had come from the used c0r39.The surgeon was satisfied it has been removed from the patient and did not request an x-ray.Additional information received via email from applied team member on november 5, 2020: i spoke with the surgeon regarding this incident this morning.His incident report is attached.Further information as stated below is that ¿leaking¿ was heard on entry of an instrument.The port was inspected appeared ok but then in replacing the port and inserting the instrument the objects in the abdomen were seen.The instrument being used in the port was a [non-applied] black stapler.Incident report received via email from user facility on 05nov2020: after i introduced an instrument through, the valve started leaking, i fully removed the part and could not see a problem, so replaced and continued to use the part.Two minutes later we saw two free pieces of the part lying in abdomen.We then pulled apart the part (pulled of black valve) and saw broken part internally.Patient status: patient is fine, no further action needed.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit were provided.Visual inspection of the photographs confirmed that the septum, an internal rubber component of the seal, was fragmented.The fragmented septum confirmed the complainant¿s experience of seal leakage.Engineering also observed that the shield, an internal plastic component of the seal, had dislodged from the seal.Based on the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of instruments (stapler) 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." the event is being reported due to the shield dislodgement that was observed in the photographs that were provided to applied medical.Seal leakage and septum fragmentation are not considered to be reportable as they are unlikely to cause or contribute to death or serious injury.

• Brand Name: C0R39,KII15X150MM 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: 10830030
• Report Number: 2027111-2020-00615
• Device Sequence Number: 3644358
• Product Code: GCJ
• UDI-Device Identifier: 00607915116446
• UDI-Public: (01)00607915116446(17)230408(30)01(10)1385003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 04/08/2023
• Device Model Number: C0R39
• Device Catalogue Number: 101415901
• Device Lot Number: 1385003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COVIDIEN BLACK STAPLER.