MAUDE Adverse Event Report: AESCULAP AG SENSATION MICRSCIS S/S BAY STR 120/245MM; SCISSOR

Model Number FM124R

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Country of complaint: (b)(6).Staff member in hospital injured by protruding instrument from outer box.Instrument had breached inner box packaging and pierced outer shipping box.

Manufacturer Narrative

The instrument arrived in a clean status and the folding box is damaged.We made a visual inspection of the folding box.We found several places of a breakthrough and visual damage inside the box.The device quality and manufacturing history records have been checked for the lot number (52206336) and found to be according to specification, valid at the time of production.The root causes of the problem is most probably process related.We assume that the several points of damage at the folding box carton were caused by transport.According to the quality standard the product has not been distributed in a condition complying with our specifications.No protection for the working end could be found.Corrected: other serious, no longer applicable.Corrected: additional into regarding injury.

Event Description

The instrument pricked one finger of one employee.

• Brand Name: SENSATION MICRSCIS S/S BAY STR 120/245MM
• Type of Device: SCISSOR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5685186
• MDR Text Key: 46779906
• Report Number: 2916714-2016-00438
• Device Sequence Number: 1
• Product Code: HRR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FM124R
• Device Catalogue Number: FM124R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Distributor Facility Aware Date: 01/16/2016
• Date Manufacturer Received: 01/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other