MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; DAVINCI XI PACK-LF

Model Number DYNJ56423K

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, during a laparoscopic procedure, a ruler from the surgical pack was used.Upon removal of the device from the patient, a piece was noted to be missing.The surgical staff did not locate the piece and it was decided not to perform procedure.A sample has been requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

When ruler was removed, a piece was missing.

• Brand Name: Medline Industries, Inc.
• Type of Device: DAVINCI XI PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17031578
• MDR Text Key: 316278976
• Report Number: 1423395-2023-00024
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10195327325480
• UDI-Public: 10195327325480
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJ56423K
• Device Catalogue Number: DYNJ56423K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2023
• 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