MAUDE Adverse Event Report: APPLIED MEDICAL CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; HET

Model Number CB030

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Unknown procedure - "no functional coagulation despite change of monopolar cable." patient status - n/a.

Manufacturer Narrative

The event unit was returned for evaluation.Upon inspection, engineering found that the scissors functioned properly and met all current specifications.Engineering tested the unit for conductivity and the components involved and met all specifications.The root cause could not be determined as engineering was unable replicate your experience.During the manufacturing assembly process, applied medical scissors are functionally inspected 100%.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.Additional information was requested and was not provided.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: HET
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5645378
• MDR Text Key: 44892892
• Report Number: 2027111-2016-00357
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)180909(30)01(10)1254611
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/09/2018
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1254611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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