MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SCISSOR,METZENBAUM,CVD, BL/BL,TC,9"

Catalog Number MDS0828523F

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the broken scissor tip was discovered broken off inside of the patient in the middle of the hysterectomy procedure.According to the facility, during the exposure of the uterus during an abdominal hysterectomy case, it was noticed that something shiny metal looking was lying on the bowel tissue.When this was noticed by the scrub tech, she immediately stopped the surgeon from continuing and the surgeon manually retrieved the piece of metal, which was concluded to be the tip of a scissor after looking at all the instruments individually.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.The actual device was returned to the manufacturer for evaluation and was confirmed to be a broken tip of the scissor.Visual inspection of photos and the actual device was performed and although it was confirmed that the jaw snapped off of the device, the actual root cause of the customer reported issue could not be determined.Due to the reported incident and 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

It was reported that the tip of the scissor was discovered broken off inside the patient in the middle of the hysterectomy procedure.

• Type of Device: SCISSOR,METZENBAUM,CVD, BL/BL,TC,9"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11504818
• MDR Text Key: 240355988
• Report Number: 1417592-2021-00046
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS0828523F
• Device Lot Number: 128573M18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention