MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; EPCH LAPAROSCOPY PACK

Catalog Number DYNJ83097

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2024 during an appendectomy procedure the gauze/sponge frayed in the patient and needed to be removed from the surgical site.Per the facility the gauze/sponge are unfolded "at times" during use.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

Event Description

According to the facility on (b)(6) 2024 during an appendectomy procedure the gauze/sponge frayed in the patient and needed to be removed from the surgical site.

• Type of Device: EPCH LAPAROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL
• MDR Report Key: 18817170
• MDR Text Key: 336735165
• Report Number: 1423395-2024-00115
• Device Sequence Number: 1
• Product Code: FDE
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ83097
• Device Lot Number: 23HMF443
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other