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

Model Number C0R50

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

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.Patient status: no patient injury indicated.

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.Correction: the address in section e1 was corrected.

Event 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10397597
• MDR Text Key: 203134358
• Report Number: 2027111-2020-00528
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)230210(30)01(10)1380572
• Combination Product (y/n): N
• PMA/PMN Number: K060629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/04/2020
• Patient Sequence Number: 1