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

Catalog Number	DYNJ54000B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during an unidentified "back" procedure the blade fell off of the handle and into the surgical site.

• Common Device Name: BUTLER LAPAROSCOPIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7624625
• Report Number: 1423395-2018-00032
• Device Sequence Number: 13496807
• Product Code: LRO
• UDI-Device Identifier: 10889942704903
• UDI-Public: 10889942704903
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: DYNJ54000B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention