MAUDE Adverse Event Report: AESCULAP AG PRESTIGE ATRA GRASPER DBL-ACT 5MM; ENDOSCOPY

Model Number 8360-10

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "the jaws of the device are not holding, the shaft of the device is moving." the event occurred during surgery.It was reported that there was no delay in surgery, no harm to the patient and no additional intervention needed.

Manufacturer Narrative

Investigation: reviewed all previous complaints ytd for similar reported events across all similar part numbers.No similar events reported.Reviewed dhr to verify all steps were completed in accordance with the pcp.All steps were completed.Verified the final audit over inspection by a qe was performed prior to shipment which included a 20 piece over inspection, which meets the defined 15 piece minimum.Reviewed training records of individuals responsible for the assembly process of this lot.Records reflect individuals were properly trained in the assembly process.Visual inspection: the returned device was missing the screw cap.The glue surrounding the screw also shows evidence of having been manipulated post cure.The cured glue around the set screw shows evidence of being loosened, as shown by the displacement separation of the glue from the rotator housing, peeling, flaking, glue surface damaged and torn.As a result of the loosened set screw, it is not fully engaging with the d/a tube, and will not hold the tube in place allowing the tube to move when actuated.Conclusion: based on the results of the investigation, it is determined that the non-conformance is a usage issue.The returned device shows evidence of tampering, post shipment.Possibly a result of improper refurbishment or other handling post delivery.No corrective action is necessary.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8112814
• MDR Text Key: 128925442
• Report Number: 2916714-2018-00038
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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
• Device Lot Number: M46069
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2018
• Date Manufacturer Received: 12/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1