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

Model Number 8360-00

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: 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.The device history records (dhr) were reviewed for the reported lot number; the devices were found to be within specification at the time of production.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

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 an unknown date.According to the complainant, during the procedure, the device was not able to be opened and the lock appeared loose.The complaint device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Although requested, additional information has not been made available.The malfunction is filed under aic reference (b)(4).

• 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 6109849072
• MDR Report Key: 12909341
• MDR Text Key: 281522202
• Report Number: 2916714-2021-00224
• 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
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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
• Device Lot Number: L50307071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• 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