MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BUTLER LAPAROSCOPIC PACK

Catalog Number DYNJ54000B

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during an unidentified "back" procedure the blade fell off of the handle and into the surgical site.This incident reportedly occurred at the beginning of the unidentified "back" procedure as the surgeon was attempting to use the blade.The fallen blade was removed from the surgical site by the surgeon via an unidentified method.No further incident reported.The unidentified "back" procedure did not last longer than expected.Per the facility contact, there was no impact to the patient, the patient's stability, or to the procedure.No serious injury or follow-up care reported.No sample was returned to the manufacturer for evaluation.Due to the need for medical intervention to remove the fallen blade from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that during an unidentified "back" procedure the blade fell off of the handle and into the surgical site.

• Type of Device: BUTLER LAPAROSCOPIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7624625
• MDR Text Key: 111846573
• Report Number: 1423395-2018-00032
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942704903
• UDI-Public: 10889942704903
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ54000B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention