MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: unknown.Event description: the facility has informed the rep that they have trocar complaints that they have not been previously sent to applied medical.Applied medical representatives are currently following up with the facility for event details.Additional information received via email on 16oct2020 from applied medical account manager, "applied 12 mm trochar that was supposed to be sharp was not and required a lot of force to place only 1 cm from liver." intervention: used non-applied product to complete case.Patient status: "no apparent injury".

Event Description

Procedure performed: unknown.Event description: the facility has informed the rep that they have trocar complaints that they have not been previously sent to applied medical.Applied medical representatives are currently following up with the facility for event details.Additional information received via email on (b)(6) 2020 from applied medical account manager: "applied 12 mm trochar that was supposed to be sharp was not and required a lot of force to place only 1 cm from liver".Intervention: used non-applied product to complete case.Patient status: "no apparent injury".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.The model and lot number were not provided.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 is unable to determine the nature of the failure and 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.

• Brand Name: UNKNOWN
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10752523
• MDR Text Key: 213896225
• Report Number: 2027111-2020-00600
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1