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

Model Number	CTR10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	11/28/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2027111-2021-00805
• Device Sequence Number: 4465016
• Product Code: GCJ
• UDI-Device Identifier: 00607915124052
• UDI-Public: (01)00607915124052(17)230924(30)01(10)1397651
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose