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

Model Number	60728
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2018
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 in-progress.All information reasonably known as of 02-oct-2018 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.(b)(4).
Event or Problem Description
It was reported the graspers were difficult to remove during the procedure.Additional information received 12-sep-2018 stated, the retrieval basket was used during a endoscopic retrograde cholangio-pancreatography (ercp) to collect a stone in common bile duct.The physician was unable to remove the stone, it was plausible the retrieval basket was stuck in the stone.After several attempts the wire was cut from outside the patient's body and the scope was withdrawn.The wire was removed when the ercp was performed on (b)(6) 2018.The patient was awake and alert with minimum pain at that time.
Additional Manufacturer Narrative
The device history record for the reported lot number, m7240e116, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 13-dec-2018 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: FOREIGN BODY RETRIEVAL BASKET
• Common Device Name: DH ENDOSCOPY GRASPING & RETRIEVING DEVICES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7928180
• Report Number: 8030647-2018-00616
• Device Sequence Number: 19262931
• Product Code: PTS
• UDI-Device Identifier: 10680651927696
• UDI-Public: 10680651927696
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K941464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 60728
• Device Catalogue Number: 991092769
• Device Lot Number: M7240E116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention