MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8701
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic sigmoid colectomy.Event description: "the distal end of trocar broke off when instrument placed pressure on it.  the broken piece was retrieved and removed." after speaking with, initial reporter, she mentioned that not all plastic pieces were able to be removed."stapler was being used at the time the trocar broke."  also, per the op note "a portion of the 12 mm port broke off inside the patient during the case.The largest portion of this was removed however smaller piece was never identified after considerable time and effort was dedicated to locating this small, likely less than 5 mm piece of plastic." additional information received via email 13apr2022 from applied medical representative: field team is unsure of the current patient status.It is unknown how the trocar was inserted or if it was broken upon entry or not.The break was not clean.Additional information received via email 14apr2022 from user facility: patient was discharged home on (b)(6) 2022.The doctor put the trocars in with a twisting motion.There was no difficulty during insertion.Product is available for return.Intervention: the largest portion of break was removed.Patient status: small plastic piece was left inside patient.Patient discharged home on (b)(6) 2022.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with one clear fragment.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.The fragment was identified to be a portion of the missing cannula tip.Based on the condition of the returned unit, it is likely that the reported event was caused by an instrument coming into contact with the tip of the cannula during the procedure.
Event or Problem Description
Procedure performed: laparoscopic sigmoid colectomy.Event description: "the distal end of trocar broke off when instrument placed pressure on it.The broken piece was retrieved and removed." after speaking with [initial reporter], she mentioned that not all plastic pieces were able to be removed."[ ] stapler was being used at the time the trocar broke." also, per the op note "a portion of the 12 mm port broke off inside the patient during the case.The largest portion of this was removed however smaller piece was never identified after considerable time and effort was dedicated to locating this small, likely less than 5 mm piece of plastic." additional information received via email 13apr2022 from applied medical representative: field team is unsure of the current patient status.It is unknown how the trocar was inserted or if it was broken upon entry or not.The break was not clean.Additional information received via email 14apr2022 from user facility: patient was discharged home on (b)(6) 2022.The doctor put the trocars in with a twisting motion.There was no difficulty during insertion.Product is available for return.Intervention: the largest portion of break was removed.Patient status: small plastic piece was left inside patient.Patient discharged home on (b)(6) 2022.

• Brand Name: C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 14190925
• Report Number: 2027111-2022-00574
• Device Sequence Number: 4556452
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)240714(30)01(10)1421852
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 07/14/2024
• Device Model Number: C8701
• Device Catalogue Number: 101473672
• Device Lot Number: 1421852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON STAPLER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown