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	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laprascopic hernia.Event description: the device was being used when performing alf deacon - laprascopic hernia.Scissors failed to cut tissue.It did not jam, the jaws closed but did not cut the tissue.Surgeon then opened another pair of epix laprascopic scissors and completed the surgery with those.There were no changes in patient health resulting from the event.Device replaced with same model scissors and successfully completed surgery intervention: device replaced with same model scissors and successfully completed surgery.Patient status: no complications arose from the event.
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.Testing was performed on the event unit, which confirmed that the returned unit was unable to cut consistently across the entire length of the blade.Engineering observed a small gap between the tips of the blades.Based on the condition of the event unit and description of the event, the scissors were unable to cut due to the gap that were observed between the tips of the blades on the returned unit.  however, the exact root cause of the gap could not be determined based on the evaluation of the returned unit.Applied medical continuously seeks to improve the form, function, and ease of use of its products.  as part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.Correction: sections d4 and h4 are being updated as the lot number was confirmed upon evaluation of the returned unit.
Event or Problem Description
Procedure performed: laprascopic hernia.Event description: the device was being used when performing alf deacon - laprascopic hernia.Scissors failed to cut tissue.It did not jam, the jaws closed but did not cut the tissue.Surgeon then opened another pair of epix laprascopic scissors and completed the surgery with those.There were no changes in patient health resulting from the event.Device replaced with same model scissors and successfully completed surgery intervention: device replaced with same model scissors and successfully completed surgery.Patient status: no complications arose from the event.

• 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: 13865282
• Report Number: 2027111-2022-00487
• Device Sequence Number: 20151646
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)240914(30)01(10)1429335
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 09/14/2024
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1429335
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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