MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	CB030
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: inguinal hernia.Event description: scissor coagulated at the level of green coating not at the level of the scissor.They took another scissor and finished the procedure without problem patient ok!.[translation]: i just received a scissor back that coagulates at the level of the green coating (where the logo of the company is) and not at the scissor section.This causes dangerous situations.Epix scissors cb030 (lot 1443223).Additional information received from applied medical representative via email on 21-mar-2022: the unit was put aside, but today they were not able to locate it to be returned for the investigation.The territory manager is trying to locate it, alternatively they potentially have footage of the incident.He described it as coagulation of connective tissue 5cm into the isolation of the scissors.Luckily it was only connective tissue, but they were very worried in case it would happen in another procedure and for example accidently puncture the colon without noticing.Additional information received from applied medical representative via email on 25-mar-2022: the incident happened during an inguinal hernia repair.The patient was not hurt.A new pair of scissors was taken and the procedure was completed.The device has been located and will be returned.Intervention: change of device.Patient status: patient ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit, where no coagulation was observed away from the scissor blades.Therefore, the complainant¿s experience of arcing to non-target tissue could not be confirmed.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Correction: section h6 (component code) is being updated to more accurately reflect the component of the device that was alleged to malfunction by the user facility.
Event or Problem Description
Procedure performed: inguinal hernia.Event description: scissor coagulated at the level of green coating not at the level of the scissor.They took another scissor and finished the procedure without problem patient ok! customer email: ik heb net een schaar terug gekregen die coaguleert ter hoogte van de groene coating (waar label van firma staat) en niet ter hoogte van het schaar gedeelte.Dit geeft zeer gevaarlijke situaties.Epix schaar cb030 (lot 1443223).[translation]: i just received a scissor back that coagulates at the level of the green coating (where the logo of the company is) and not at the scissor section.This causes dangerous situations.Epix scissors cb030 (lot 1443223).Additional information received from applied medical representative via email on 21-mar-2022: the unit was put aside, but today they were not able to locate it to be returned for the investigation.The territory manager is trying to locate it, alternatively they potentially have footage of the incident.He described it as coagulation of connective tissue 5cm into the isolation of the scissors.Luckily it was only connective tissue, but they were very worried in case it would happen in another procedure and for example accidently puncture the colon without noticing.Additional information received from applied medical representative via email on 25-mar-2022: the incident happened during an inguinal hernia repair.The patient was not hurt.A new pair of scissors was taken and the procedure was completed.The device has been located and will be returned.Intervention: change of device.Patient status: patient ok.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• 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: 13968303
• Report Number: 2027111-2022-00538
• Device Sequence Number: 14696323
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250203(30)01(10)1443223
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062169
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1443223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown