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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

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 Description

Procedure performed: unknown.Event description: during an informal conversation with the operating room chief nurse, i was told that a patient suffered an injury (bowel perforation) during a surgery where our trocars were being used; this information has also been confirmed by the chief of surgery; they only found out a few days later when patient was recovering from the intervention; because they were also using other instruments and devices from other brands (not from applied medical), it was not possible to establish the casuality of the event.Additional information received from applied medical representative via email on 10-dec-2021: the date of the surgery cannot be confirmed.The type of trocar is uncertain.The surgeon used at least one ea ctf73 and two ea ctb03.No malfunctions were noticed at any time.Other information has not been provided.This was not a claim from the customer, the information was received during an informal conversation.The customer prefers not to provide more details.Patient status: unknown.

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 Description

Procedure performed: unknown.Event description: during an informal conversation with the operating room chief nurse, i was told that a patient suffered an injury (bowel perforation) during a surgery where our trocars were being used; this information has also been confirmed by the chief of surgery; they only found out a few days later when patient was recovering from the intervention; because they were also using other instruments and devices from other brands (not from applied medical), it was not possible to establish the casuality of the event.Additional information received from applied medical representative via email on 10-dec-2021: the date of the surgery cannot be confirmed.The type of trocar is uncertain.The surgeon used at least one ea ctf73 and two ea ctb03.No malfunctions were noticed at any time.Other information has not been provided.This was not a claim from the customer, the information was received during an informal conversation.The customer prefers not to provide more details.Patient status: unknown.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: unknown.Event description: during an informal conversation with the or chief nurse, i was told that a patient suffered an injury (bowel perforation) during a surgery where our trocars were being used; this information has also been confirmed by the chief of surgery; they only found out a few days latter when patient was recovering from the intervention; because they were also using other instruments and devices from other brands (not from applied medical), it was not possible to establish the causality of the event.Additional information received from applied medical representative via email on 10-dec-2021: the date of the surgery cannot be confirmed.The type of trocar is uncertain.The surgeon used at least one ea ctf73 and two ea ctb03.No malfunctions were noticed at any time.Other information has not been provided.This was not a claim from the customer, the information was received during an informal conversation.The customer prefers not to provide more details.Patient status: unknown.

• Brand Name: UNKNOWN
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12990060
• MDR Text Key: 285329101
• Report Number: 2027111-2021-00772
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1