MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LAP CHOLE I

Catalog Number DYNJS0310

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  Injury  

Event Description

According to the facility on (b)(6) 2023 "the raytec was being used to stop a bleeding area on a laparoscopic case within the abdomen being held by a laparoscopic grasper".

Manufacturer Narrative

According to the facility on (b)(6) 2023 "the raytec was being used to stop a bleeding area on a laparoscopic case within the abdomen being held by a laparoscopic grasper".Per the facility the gauze tore into pieces while in the abdomen and were removed surgically during the same procedure.Per the facility the procedure was able to be completed and the patient was discharged from the hospital.No additional information is available at this time.The sample was requested for evaluation.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.

• Type of Device: LAP CHOLE I
• 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: 18133700
• MDR Text Key: 328077367
• Report Number: 1423395-2023-00072
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10080196942589
• UDI-Public: 10080196942589
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJS0310
• Device Lot Number: 23EBH264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other