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

Model Number CB030

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: unknown.Monopolar plug did not work with two different scissors from that lot, they then used another lot number an it worked.Additional information received from applied medical representative via email on (b)(6)2021: instruments have been used and did not work.Additional sterile units of the same lot will be returned.Intervention: change of device (same lot) procedure performed: no patient injury.

Event Description

Procedure performed: unknown.Monopolar plug did not work with two different scissors from that lot , they then used another lot number an it worked.Additional information received from applied medical representative via email on 08-feb-2021: 2 instruments have been used and did not work.5 additional sterile units of the same lot will be returned.Intervention: change of device (same lot).Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, 5 representative sterile units were returned.Testing was performed on the representative units; however, the complainant¿s experience could not be replicated or confirmed as the representative units met current specifications.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause based on the evaluation of the representative sterile units and the description of the event.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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
• MDR Report Key: 11319077
• MDR Text Key: 258946175
• Report Number: 2027111-2021-00330
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)230917(30)01(10)1396749
• Combination Product (y/n): N
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1396749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1