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

Catalog Number DYNJ0751465U

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  malfunction  

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 Description

It was reported that the gauze unraveled while inside of a patient.

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.

• Type of Device: GAUZE IN LAPAROSCOPY PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8901195
• MDR Text Key: 159369976
• Report Number: 1423395-2019-00028
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942966424
• UDI-Public: 10889942966424
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0751465U
• Device Lot Number: 19FKB119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR