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

Model Number CB030

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Engineering confirmed the customer's experience of the dirty and damaged packaging.During the manufacturing process, white boxes and the packaged units inside are periodically inspected for damage.The root cause of the customer's experience is likely due to the unit being run over by an object with a wheel, although it cannot be confirmed when this happened.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.This report represents the initial and final report.Applied medical deems this event non- reportable as it is unlikely to cause or contribute to death or serious injury.This report is a follow-up to medwatch # (b)(4).

Event Description

The packaging was damaged and dirty prior to use.Inner pouch that has the plastic that has the device in it.Not the outer hard box.She thinks the dirt was on the outside, not the inside of the packaging.Noticed in the operating room.For additional questions, contact (b)(6).Patient status: not used in patient additional information received via medwatch (b)(4): "title: xxxxx event desc: packaging was damaged and dirty prior to use.Device usage problem: other" additional information received via email on october 13, 2016 from customer: "we keep each individual item in the applied medical packaging that it comes in on the shelf.Sometimes "an each" is pulled for a case and it does not get used so it comes back down.I always try and keep "loose eaches" in the original pkg.".

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6189340
• MDR Text Key: 62858614
• Report Number: 2027111-2016-00902
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00607915110123
• UDI-Public: (01)00607915110123(17)190707(30)01(10)1272954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062169
• 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
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/07/2019
• Device Model Number: CB030
• Device Catalogue Number: 101419701
• Device Lot Number: 1272954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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