MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX; HET

Model Number	CB040
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: staff thought that the packaging had a hole in it, looks like it was melted.There was no risk or impact associated with this complaint, there was no delay to case and another device was opened.The product is used weekly; the product for return is not contaminated and ready for collection by the rep.The rep has notified the hospital of the "indentation" as being part of the packaging to hold the device upright and does not compromise sterility.Type of intervention: another device opened patient status: fine.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Visual inspection confirmed the complainant?s experience of a hole in the mylar side of the pouch.Black marks were observed on the tyvek side of the pouch.Based on the condition of the returned unit, it is likely that the hole was caused after shipment and removal from the product box.The damage to the pouch suggests that the pouch was caught between two objects and dragged, which resulted in a hole in the pouch.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.

• Brand Name: CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6850630
• Report Number: 2027111-2017-01997
• Device Sequence Number: 117674
• Product Code: HET
• UDI-Device Identifier: 00607915110130
• UDI-Public: (01)00607915110130(17)191201(30)01(10)1284541
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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
• Operator of Device: Other
• Device Expiration Date: 12/01/2019
• Device Model Number: CB040
• Device Catalogue Number: 101080402
• Device Lot Number: 1284541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1