MAUDE Adverse Event Report: APPLIED MEDICAL CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; FZP

Model Number CA500

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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

Laparoscopic cholecystectomy - "clip applier was used through kii 5mm trocar.During insertion of clip, small shavings from inside of trocar were found in the patient.The shavings were retrieved and the case concluded with no further incident." patient status - no patient harm.

Manufacturer Narrative

Investigation summary: one (1) ca500 and one (1) cts02 trocar sleeve was returned for evaluation.Upon inspection, engineering found that the cover tube over the shaft was flared out near the jaws.Engineering inserted the returned device through the returned trocar to replicate the customer experience.During insertion of the clip applier through the trocar, engineering confirmed the experience noting plastic shavings had scrapped off the inside of the trocar.All clip appliers undergo 100% visual and functional inspection during the manufacturing and assembly.As a part of this process, each unit is inspected for clip feeding during manufacturing prior to packaging.Applied medical is currently investigating process enhancements which are intended to reduce the potential for this type of incident to reoccur.We apologize for any inconvenience this may have caused and assure you that applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance, safety, and efficacy of the products.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.Additional information was requested and provided.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: FZP
• 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: 5355325
• MDR Text Key: 35801634
• Report Number: 2027111-2016-00015
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/19/2018
• Device Model Number: CA500
• Device Catalogue Number: 101281901
• Device Lot Number: 1252906
• Other Device ID Number: 00607915125318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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