MAUDE Adverse Event Report: AESCULAP INC PRESTIGE ATRA GRASPER DBL-ACT 5MM; ENDOSCOPY INSTRUMENTS

Model Number 8360-10

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation confirmed that the upper jaw was broken off.The insulation was also gouged near the distal end and the rails were broken off.Root cause: it was determined that the endoscopic grasper was misused and used forcefully.Conclusion: the issue was found to be due to excessive mechanical stress and improper care and handling.A capa is not required.

Event Description

It was reported that the upper jaw was broken on the prestige endoscopic grasper.The issue was noted during processing and did not involve a patient or procedure.

Manufacturer Narrative

Lot # of device - l50406916.Manufacturing site evaluation: previously reported.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8075239
• MDR Text Key: 128742729
• Report Number: 2916714-2018-00036
• Device Sequence Number: 1
• Product Code: NWV
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Device Lot Number: L50406916
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/14/2019
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1