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

Model Number CB030

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

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 Description

Procedure performed: inguinal hernia.Event description: scissors not sharp at the distal end which makes dissection during procedure more dangerous.Patient ok! patient status: patient ok.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit; however, the event unit was able to cut properly along the entire length of the scissor blade.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause of the event or confirm that a product malfunction occurred.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.

Event Description

Procedure performed: inguinal hernia.Event description: complaint 1 of 6: (b)(4) [mfr #2027111-2022-00441]; complaint 2 of 6: (b)(4) [mfr #2027111-2022-00443]; complaint 3 of 6: (b)(4) [mfr #2027111-2022-00444]; complaint 4 of 6: (b)(4) [mfr #2027111-2022-00446]; complaint 5 of 6: (b)(4) [mfr #2027111-2022-00447]; complaint 6 of 6: (b)(4) [mfr #2027111-2022-00448].Scissors not sharp at the distal end which makes dissection during procedure more dangerous.Patient ok! intervention: no information.Patient status: patient ok.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: 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: 13686211
• MDR Text Key: 288806343
• Report Number: 2027111-2022-00446
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)241115(30)01(10)1435498
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1435498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1