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

Model Number CB030

Device Problem Dull, Blunt (2407)

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: hernia repair.Hospital: [name].This is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Could not cut a tissue.Report from the sales rep: it could not cut a tissue in the beginning of the procedure.Initial investigation report: the two event units were returned to us and visually inspected.From the appearance, we couldn't confirm any abnormalities or differences in the scissors.The units will be returned to amr for further evaluation.Admin# (b)(4).Additional information received via email on 07jan2021 from olympus quality assurance engineer.The device was non-functional upon initial use."the customer was cut a tissue." the two (units) sent were used on different days, and they were immediately replaced with the same product, and the procedure was completed.The other day was unknown.Intervention: "immediately replaced with the same product, and the procedure was completed." patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed that the unit was unable to cut consistently across the entire length of the blade.Engineering observed that there was a 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 event unit.It is unknown whether the gap was a pre-existing device non-conformance or caused by use.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure name: "hernia repair" hospital: [name] this is a complaint from the market.Administrative no.C20653373.Please refer to the complaint sheet for investigation.Could not cut a tissue report from the sales rep it could not cut a tissue in the beginning of the procedure.Initial investigation report the two event units were returned to us and visually inspected.From the appearance, we couldn¿t confirm any abnormalities or differences in the scissors.The units will be returned to amr for further evaluation.Admin# c20653373.Additional information received via email on (b)(6) 2021 from olympus quality assurance engineer the device was non-functional upon initial use."the customer was cut a tissue." the two (units) sent were used on different days, and they were immediately replaced with the same product, and the procedure was completed.The other day was unknown.Complaint 2021-000030 has been created to address the 2nd unit used on the unknown date intervention: they were immediately replaced with the same product, and the procedure was completed.Patient status: no patient injury.

• 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: 11165107
• MDR Text Key: 228875324
• Report Number: 2027111-2021-00306
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)230313(30)01(10)1383853
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/13/2023
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1383853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1