MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTB73

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

Procedure performed: unknown.Event description: limited information available when reported.Received a trocar that failed to disengage.Additional information received via email on 10jul2019 from applied medical account mgr "[name] did get back to me on the preliminary questions i asked.No patient injury or illness occurred.Surgeon: [name].Another device was used with no problem.( i asked for clarification on this, brand, item #, lot #) the device was kept." intervention: another device was used with no problem.Patient status: no patient injury or illness occurred.

Event Description

Procedure performed: unknown.Event description: limited information available when reported.Received a trocar that failed to disengage.Additional information received via email on 10jul2019 from applied medical account mgr: "no patient injury or illness occurred.Surgeon: [name].Another device was used with no problem.( i asked for clarification on this, brand, item #, lot #) the device was kept." additional information received via email on 30jul2019 from applied medical account mgr: date of the event was may 20 2019.The procedure performed was a lap ap.Yes, the trocar was used on the patient.The blade did not engage.Report does not state at what point in the procedure the non-conformance was identified.Another device was used.We do not document lot numbers.Intervention: another device was used with no problem.Patient status: no patient injury or illness occurred.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the blade was not able to engage.Based on the condition of the returned unit, it is likely that the reported event was caused by an incomplete press fit during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible process enhancements intended to further minimize the potential for this type of event to occur.The event was determined to be reportable based on the original description of the event.However, upon receipt of additional information and evaluation of the returned unit, the event is not reportable as it is unlikely to cause or contribute to death to serious injury.

• Brand Name: CTB73, 12X100 KII SH BLD 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: 8814243
• MDR Text Key: 151949803
• Report Number: 2027111-2019-00521
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)220121(30)01(10)1346924
• Combination Product (y/n): N
• PMA/PMN Number: K072674
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1346924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1