MAUDE Adverse Event Report: AVANOS MEDICAL INC. FOREIGN BODY RETRIEVAL HOOD PROTECTOR; DH ENDOSCOPY GRASPING & RETRIEVING DEVICES

Model Number	69392
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6) 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported "the foreign body hood retriever came off of the scope & lodged in the [patient's] cricopharyngeus".There was no reported injury.

• Brand Name: FOREIGN BODY RETRIEVAL HOOD PROTECTOR
• Common Device Name: DH ENDOSCOPY GRASPING & RETRIEVING DEVICES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9098095
• Report Number: 8030647-2019-00089
• Device Sequence Number: 2486180
• Product Code: FED
• UDI-Device Identifier: 00350770928104
• UDI-Public: 00350770928104
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K841258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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 Model Number: 69392
• Device Catalogue Number: 109281002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1