MAUDE Adverse Event Report: AESCULAP AG DISP.METZENBAUM SCISSORS D:5/310MM; DISPOSABLE INSTRUMENTS

Model Number PO840SU

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a disposable metzenbaum scissors.According to the complaint description the scissors did not cut during surgery.There was no patient harm reported.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Vigilance investigator carried out the pictorial documentation visually and microscopically.The provided pair of scissors failed a cutting performance test.The scissors are subjected to a cutting performance test during montage and before packing.Therefore we exclude a manufacturing related error.The inadequate cutting performance could be caused by a damage of the blades during handling, e.G.Leverage or torsion during application.

• Brand Name: DISP.METZENBAUM SCISSORS D:5/310MM
• Type of Device: DISPOSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10482865
• MDR Text Key: 207344588
• Report Number: 9610612-2020-00476
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K010752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO840SU
• Device Catalogue Number: PO840SU
• Device Lot Number: 52610173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1