MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTF73

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

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 investigation.This report is to follow-up medwatch #(b)(4).

Event Description

Procedure performed: laparoscopic gastric bypass.Event description: medwatch # (b)(4) received via mail on 16sep2020.Event date on the medwatch form is august 2020.During a laparoscopic gastric bypass procedure, a trocar part was leaking.The procedure was still completed as planned without excessive delay or harm to the patient.Intervention: the procedure was completed as planned.Patient status: no harm to the patient.

Event Description

Procedure performed: laparoscopic gastric bypass.Event description: medwatch # (b)(4) received via mail on 16sep2020.Event date on the medwatch form is august 2020.During a laparoscopic gastric bypass procedure, a trocar part was leaking.The procedure was still completed as planned without excessive delay or harm to the patient.Additional information received via email on 24sep2020 from user facility: the part of the trocar that was leaking was unspecified in staff report.They simply stated "port is leaking" no component separation.The same trocar was used to complete the procedure.The staff was unable to comment on what instrumentation was being used at the time of the incident.The device was not saved.Intervention: the procedure was completed as planned patient status: no harm to the patient.

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 seal leakage could not be confirmed.In the absence of the event unit, it is difficult to determine if the seal leakage 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 based on the description 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.Seal leakage is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow-up medwatch # (b)(4).

• Brand Name: CTF73, 12X100 KII FIOS ZTHR 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: 10570617
• MDR Text Key: 213906484
• Report Number: 2027111-2020-00561
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)230302(30)01(10)1382749
• Combination Product (y/n): N
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1382749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 184