MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-10

Device Problem Break (1069)

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

Event Date 08/11/2022

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 a laparoscopic inguinal hernia repair procedure performed on (b)(6) 2022.According to the complainant, during the procedure, when the surgeon went to use the device, a proximal weld breakage was observed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device revealed that the proximal weld failed between handle subassembly and rotator block.As a result of this failure, the actuator and distal jaw subassembly were not able to be rotated independently from the handle.The device distal jaw assembly remained in-tact.The device history records (dhr) were not able to be reviewed as no lot # was available for the returned device.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.The investigation into the cause of the reported problem was able to confirm the failure mode of proximal weld breakage.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• 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: 15422473
• MDR Text Key: 306276973
• Report Number: 2916714-2022-00090
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/14/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/14/2022
• 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