MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; HANDHELD PRODUCTS & LIGATION

Model Number 8360-10

Device Problem Break (1069)

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

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part # 8360-10) was used during a laparoscopic appendectomy procedure on january 8 2024.According to the complainant the grasper broke during a procedure.All pieces were successfully retrieved.An x-ray was performed and confirmed no fragments were left inside the patient.An unspecified delay to the procedure was reported.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).

Manufacturer Narrative

Updated information: h2, h6 codes updated.A picture of the device failure was sent.The picture included visible evidence of damage.The jaws of the device were shattered/broken.The picture confirmed that the jaws of the prestige grasper was broken/shattered.An approved project is in place to further address issues relating to the prestige grapser jaws breaking.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 18545474
• MDR Text Key: 333271872
• Report Number: 2916714-2024-00001
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention