MAUDE Adverse Event Report: AESCULAP AG AESCULAP; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number PO888

Device Problems Material Fragmentation (1261); Contamination of Device Ingredient or Reagent (2901); Packaging Problem (3007)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Packaging for the laparoscopic metzenbaum scissors shred upon opening¿contaminating the item so it can not be used.Opened another pair.The incident has happened several times recently.Aesculap metzenbaum ref po888, lot 52717883, exp 09/29/2026.

• Brand Name: AESCULAP
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 15390938
• MDR Text Key: 299574179
• Report Number: 15390938
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PO888
• Device Catalogue Number: PO888
• Device Lot Number: 52717883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female