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

Model Number 8360-00

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported to aesculap inc.That two (2) prestige atra slide lock graspers (part # 8360-00) were used during a laparoscopic procedure performed during the week of (b)(6) 2020.According to the complainant, the upper and lower jaws were broken during use on the first prestige graspers device.A second prestige graspers device (ref.Mdr id 2916714-2020-00729) was used, which resulted in the detachment of the upper jaw.Reportedly, fragments from one of the two devices detached into the patient, but were retrieved without issue.The procedure was then successfully completed using a third prestige grasper device.The complaint devices are available to be returned to the manufacturer for evaluation.No known adverse patient effects occurred as a result of the fragment retrieval.Additional information has been requested, but has not been made available.The adverse event / malfunction is filed under aag reference xc (b)(4).

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.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the lot # was not provided for the device in question.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.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.

Event Description

No update required.

• 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: 11210804
• MDR Text Key: 230754698
• Report Number: 2916714-2020-00728
• 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: 11/30/2021

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: 8360-00
• Device Catalogue Number: 8360-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention