MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R50
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 investigation.
Event or Problem Description
Procedure performed: unknown.Event description: medwatch received via mail on 02nov2020.Medwatch uf/importer report # (b)(4).The event date is unknown.The event occurred in (b)(6) 2020."trocar broke during surgery.A rubbery piece of the time broke off and fell into the patient.The pieces were able to be retrieved." patient status: no patient injury indicated.
Event or Problem Description
Procedure performed: "robotic procedures." event description: medwatch received via mail on 02nov2020.Medwatch uf/importer report #(b)(4).The event date is unknown.The event occurred in (b)(6) 2020."trocar broke during surgery.A rubbery piece of the time broke off and fell into the patient.The pieces were able to be retrieved." additional information received via email on 19nov2020 from user facility: the device was used in robotic procedures.The case was completed with a new trocar.It is believed the trocar was used as a camera port.A piece of the seal fell into the patient but it was retrieved.The device is not available for return.The device is not available for return.Intervention: "got new trocar." patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is to follow-up medwatch report #(b)(4).

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 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: 10833250
• Report Number: 2027111-2020-00618
• Device Sequence Number: 3644360
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)230615(30)01(10)1384977
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 06/15/2023
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1384977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR