MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; GENERAL LAPAROSCOPY

Model Number DYNJ903234C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2022

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2022 during a laparoscopic procedure, 'the raytec gauze are being used to wipe the trocar sites out and leaving fibers in the surgical site'.

Manufacturer Narrative

According to the facility on (b)(6) 2022 during a laparoscopic procedure, 'the raytec gauze are being used to wipe the trocar sites out and leaving fibers in the surgical site'.Per the facility the 'strings are removed with a grasper from the surgical site without serious injury or impact to the patient.Per the facility there was no reported adverse outcome and the procedure was completed without issue.The sample was returned for evaluation, but a definitive root cause could not be determined at this time.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Type of Device: GENERAL LAPAROSCOPY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15914849
• MDR Text Key: 304792431
• Report Number: 1423395-2022-00041
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10195327187828
• UDI-Public: 10195327187828
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ903234C
• Device Catalogue Number: DYNJ903234C
• Device Lot Number: 22GBB562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention