MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GAUZE IN LAPAROSCOPY PACK-LF

Catalog Number	DYNJ0751465U
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified procedure the gauze unraveled while inside of a patient.Despite multiple good-faith attempts, the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the manufacturer.The use of the gauze during the unidentified procedure is unknown.No impact or adverse effect to the patient or to the unidentified procedure was originally reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gauze unraveled while inside of a patient.
Additional Manufacturer Narrative
The manufacturer received additional information from the reporting facility.Reportedly, at the end of a prostatectomy procedure, the gauze was identified to have unraveled within the surgical site.A pair of forceps was used by the surgeon to remove the gauze material from the surgical site.The patient was under general anesthesia at the time of the incident.The administration of additional anesthesia was not required.There was no impact or adverse effect to the patient.No sample was returned to the manufacturer for evaluation.If additional relevant information becomes available, another supplemental medwatch will be filed.

• Common Device Name: GAUZE IN LAPAROSCOPY PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8901195
• Report Number: 1423395-2019-00028
• Device Sequence Number: 18986879
• Product Code: FDE
• UDI-Device Identifier: 10889942966424
• UDI-Public: 10889942966424
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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 Catalogue Number: DYNJ0751465U
• Device Lot Number: 19FKB119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR