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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: [name] provided the following information via email on 9 august 2022: we have received a cer complaint from [user facility].Call was made to customer relations team yesterday from [name].This is all of the information he has and i do not have any more information at this stage from theatres: product code: cb030.Lot: 1453534.Date of issue: (b)(6) 2022.Issue: scissors were not closing properly.Procedure and surgeon is unknown.Cn submitted the form but person is unknown at this stage ¿ signature only appears without name printed on form.Limited information has been received by materials management team however they have the product in a bag ready to be picked up.Additional information received via email from [name] on 15aug2022: the scissor blades would get caught and not open properly.The patient was not affected.They used another one exactly the same with no problem.Intervention: they used another one exactly the same with no problem.Patient status: the patient was not affected.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of rough actuation.A burr was observed on one of the blades.The rivet, a metal component of the device, was also observed to be improperly swaged.Based on the condition of the returned unit, it is likely that the reported event was caused by the burr, which formed from the scissor blades interfering with one another.The blades likely interfered with one another because of the improperly swaged rivet.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: ni.Event description: [name] provided the following information via email on 9 august 2022: we have received a cer complaint from [user facility].Call was made to customer relations team yesterday from [name].This is all of the information he has and i do not have any more information at this stage from theatres: product code: cb030 lot: 1453534 date of issue: july 15 2022 issue: scissors were not closing properly procedure and surgeon is unknown cn submitted the form but person is unknown at this stage ¿ signature only appears without name printed on form limited information has been received by materials management team however they have the product in a bag ready to be picked up.Additional information was received via email from [name] on 15 august 2022: the scissor blades would get caught and not open properly the patient was not affected they used another one exactly the same with no problem intervention: they used another one exactly the same with no problem patient status: the patient was not affected.

• 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: 15325020
• Report Number: 2027111-2022-00718
• Device Sequence Number: 20381717
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)250518(30)01(10)1453534
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 05/18/2025
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1453534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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