MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE RETR GRASPER SGL-ACT 5MM36CM; HANDHELD PRODUCTS & LIGATION

Model Number 8361-00

Device Problem Break (1069)

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

Event Date 11/14/2023

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 retr grasper sgl-act 5mm36cm (part#: 8361-00) was used during a lap chole procedure on (b)(6) 2023.According to the complainant the device had broken off inside the patient.Reportedly an x-ray was required to locate the broken piece.The fragment was able to be retrieved from the patient.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.One (1) used sample was returned with visible evidence of damage.The jaws of the device were broken and did not open or close.Therefore the defect is confirmed.An approved project is in place to further address issues with the graspers breaking.

• Brand Name: PRESTIGE RETR GRASPER SGL-ACT 5MM36CM
• 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: 18349312
• MDR Text Key: 330814421
• Report Number: 2916714-2023-00124
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083398
• UDI-Public: 4046955083398
• 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: 01/12/2024

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 Operator: Health Professional
• Device Model Number: 8361-00
• Device Catalogue Number: 8361-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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