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
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: ni.Event description: the balloon tip broke off when inserting into the patient.From materials management: the event date is currently unknown.It is unknown if the product is available for return.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 of a damaged cannula tip could not be confirmed.In the absence of the event unit, it is difficult to determine if the damaged cannula tip 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 root cause at this time.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Event 1 of 2: medwatch # 2027111 - 2020 - 00528.Event 2 of 2: medwatch # 2027111 - 2020 - 00549.Procedure performed: ni.Event description: "the balloon tip broke off when inserting into the patient." additional information received via phone on 04aug2020 from hospital materials management: the report was filed within the facility on 03aug2020.The event date is currently unknown.Additional information received via email on 04sep2020 from hospital rn: the balloon on the trocar leaked during the case.It was a slow leak and no pieces were left in the patient.The case was completed with another c0r50 trocar.The patient status was fine.There was no patient injury.Type of intervention: the case was completed with another c0r50 trocar.Patient status: no patient injury indicated.

• 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: 10491722
• Report Number: 2027111-2020-00549
• Device Sequence Number: 19681798
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)230210(30)01(10)1380572
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 02/10/2023
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1380572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/02/2020
• Patient Sequence Number: 1