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

Model Number CNO11

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit returned for evaluation.A follow-up report will be provided upon completion of investigation.

Event 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 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.

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
• Type of Device: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8834213
• MDR Text Key: 177978606
• Report Number: 2027111-2019-00532
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915134440
• UDI-Public: (01)00607915134440(17)211029(30)01(10)1338892
• Combination Product (y/n): N
• PMA/PMN Number: K171701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1