MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-00

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported to aesculap inc.That a prestige atra graspersgl-act5mm 36cm (part # 8360-00) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the grasper jaw would not open when the surgeon attempted to use it.Reportedly, the jaw broke off as the device was looked at by the technician.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

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

Manufacturer Narrative

Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device revealed, that the distal jaw assembly had become disassembled.Additionally, a portion of the link was missing at the distal tip.An investigation of the device manufacturing records was not able to be conducted by the manufacturer, as the lot # was not 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.The investigation into the cause of the reported problem was able to confirm, the failure mode of distal jaw housing disassembled.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 GRASPERSGL-ACT5MM 36CM
• 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: 14439350
• MDR Text Key: 293607163
• Report Number: 2916714-2022-00054
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083367
• UDI-Public: 4046955083367
• 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,Followup
• Report Date: 06/24/2022

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: 8360-00
• Device Catalogue Number: 8360-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/24/2022
• 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