MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR10, 5X150MM KII OPT ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTR10

Device Problem Break (1069)

Patient Problem Abdominal Pain (1685)

Event Date 11/28/2021

Event Type  Injury  

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: translation: the trocar broke in the abdominal wall when the surgeon inserted a forceps into it.Patient or user impacts: emergency consultation for abdominal pain on (b)(6) 2021 then return home.Severity: critical.Declaration to the ansm: yes.Patient status: emergency consultation for abdominal pain on (b)(6) 2021 then return home.

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.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: translation: the trocar broke in the abdominal wall when the surgeon inserted a forceps into it.Patient or user impacts: emergency consultation for abdominal pain on (b)(6) 2021 then return home.Severity: critical.Declaration to the ansm: yes.Patient status: emergency consultation for abdominal pain on (b)(6) 2021 then return home.

• Brand Name: CTR10, 5X150MM KII OPT ZTHR DP 10/BX
• 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: 13122621
• MDR Text Key: 285563607
• Report Number: 2027111-2021-00805
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915124052
• UDI-Public: (01)00607915124052(17)230924(30)01(10)1397651
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: CTR10
• Device Catalogue Number: 101417401
• Device Lot Number: 1397651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose