MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM; ANOSCOPE AND ACCESSORIES

Model Number	CNO11
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: the product did not pass the incoming inspection of po#19-02app because of torn packaging.Details are shown on the attached file.Type of intervention: na.Patient status: no patient involved.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: the product did not pass the incoming inspection of po#: (b)(4) because of torn packaging.Type of intervention: na.Patient status: no patient involved.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering observed minor creases and scuffs on the c-film side of the pouch.Engineering also confirmed that there was a hole in the tyvek of the pouch.Based on the condition of the returned unit, the reported event was caused by the interaction between the tray edge and the pouch.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CNO11, GELPOINT PATH, 5.5CM
• Common Device Name: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8834213
• Report Number: 2027111-2019-00532
• Device Sequence Number: 2513890
• Product Code: FER
• UDI-Device Identifier: 00607915134440
• UDI-Public: (01)00607915134440(17)211029(30)01(10)1338892
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: CNO11
• Device Catalogue Number: 101424301
• Device Lot Number: 1338892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1