MAUDE Adverse Event Report: APPLIED MEDICAL C5223, REUSABLE GRASPER HANDLE; NWV

Model Number C5223

Device Problem Sticking (1597)

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

Event Date 09/21/2015

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

Arthroscopic gastric sleeve proceedure - "handle is sticking the disposable for this handle is fine it is just the handle isn't opening & closing properly." patient status - "fine, at home".

Manufacturer Narrative

Full udi# provided.(b)(4).Additional information was requested and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering found a burr at the end of the rod attachment.Burrs can cause friction and sticking during opening and closing of the handle.The root cause of the damage is likely due to normal wear.During the manufacturing and assembly process, applied medical graspers are functionally tested 100%.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: C5223, REUSABLE GRASPER HANDLE
• Type of Device: NWV
• 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: 5160496
• MDR Text Key: 28976761
• Report Number: 2027111-2015-00752
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C5223
• Device Catalogue Number: 100831801
• Device Lot Number: 1214666
• Other Device ID Number: 00607915116972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1