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

Model Number 8360-10

Device Problem Flaked (1246)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part # 8360-10) was used during an unspecified procedure on (b)(6) 2024.According to the complainant the insulation coating on the device started to peel during the procedure.No patient complications were reported as a result of this event.The adverse event is filed under aic reference: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Manufacturer Narrative

Additional information: this supplemental is being generated due to the receipt of a facility medwatch report mw5153566 that is related to this event.

• 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: 18597422
• MDR Text Key: 335079231
• Report Number: 2916714-2024-00003
• 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,Followup
• Report Date: 05/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/12/2024; Not provided
• Supplement Dates FDA Received: 03/21/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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