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

Model Number 8360-10

Device Problem Device Contamination With Biological Material (2908)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: usa.Bioburden was found inside the instrument.

Manufacturer Narrative

Manufacturing evaluation: the device was not available for return.Failure analysis without product: according to the instructions for use (ifu), the device is packaged "nonsterile- reusable".The ifu specifically states under how supplied: aesculap prestige endoscopic graspers are provided non-sterile, packaged one per box.Each instrument must be sterilized before use according to the procedures described in the sterilization section of this ifu document.Section 8, sterilization, page 10 of the ifu, gives instructions on how to sterilize the device including minimum exposure time and temperature.Neither micro nor aesculap made any claims that the device would be sterile upon receipt by the end user.If it was after sterilization that bioburden was found then the end customer did not follow proper instructions for sterilization.

Event Description

Further clarification: it was reported that the repair technician took apart a prestige atra grasper and found what was noted as bio burden inside the instrument.The reported incident did not occur during surgery and as such there was not impact to any patient; there were no reports of the incident causing of contributing to a serious injury or death.This incident did not contribute to a delay in surgery.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): MICRO; 100 belmont drive; somerset NJ 08873
• MDR Report Key: 7314341
• MDR Text Key: 101716874
• Report Number: 2916714-2018-00006
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Distributor Facility Aware Date: 04/12/2019
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other