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); Difficult to Open or Close (2921)

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

Event Date 11/14/2021

Event Type  malfunction  

Event Description

Procedure performed: unk.Event description: there were three units bundled together that appeared to be the units from (b)(4)[mfr 2027111-2021-00778], (b)(4) [mfr 2027111-2021-00779], and (b)(4) [mfr 2027111-2021-00780].These complaints have an event and alert date from (b)(6) 2021.There was also an additional unit with them, the packaging on that unit was marked ¿do not dispose!! faulty products for [name] (b)(6) 2021.There was also a piece of paper from a service request that was dated (b)(6) 2021, submitted by [name], for a unit from lot 1429335 and appeared to be associated with the extra unit.The description of the issue states: "the handle was not opening and closing smoothly and the scissors appeared to be blunt." how the patient was affected: "had to open another scissor".I have attached photos of the units, packaging, and service request.Intervention: had to open another scissor.Patient status: no patient injury or illness occurred associated with the complaint event.

Manufacturer Narrative

The event device has returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

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.No rough actuation was observed while actuating the handle of the device.Therefore, the complainant¿s experience of blades do not cut was confirmed, while the experience of rough actuation could not be confirmed.Based on the condition of the returned unit and the description of the event, the scissors were unable to cut due to the gap that was 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.Additionally, the root cause of the rough actuation could not be determined as the device was able to actuate smoothly.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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: section d9 is being corrected as the initial medwatch #2027111-2022-00449 had the incorrect date recorded.

Event Description

Procedure performed: unk.Event description: there were three units bundled together that appeared to be the units from (b)(4) [mfr 2027111-2021-00778], (b)(4) [mfr 2027111-2021-00779], and (b)(4) [mfr 2027111-2021-00780].These complaints have an event and alert date from (b)(6) 2021.There was also an additional unit with them, the packaging on that unit was marked "do not dispose!! faulty products for [name] 14/11/21 (14nov2021).There was also a piece of paper from a service request that was dated 15nov2021, submitted by [name], for a unit from lot 1429335 and appeared to be associated with the extra unit.The description of the issue states: "the handle was not opening and closing smoothly and the scissors appeared to be blunt." how the patient was affected: "had to open another scissor".I have attached photos of the units, packaging, and service request.Intervention: had to open another scissor.Patient status: no patient injury or illness occurred associated with the complaint event.

• 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: 13691123
• MDR Text Key: 296844818
• Report Number: 2027111-2022-00449
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)240914(30)01(10)1429335
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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: 1429335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• 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