MAUDE Adverse Event Report: AESCULAP INC PRESTIGE ATRA GRASPER DBL-ACT 5MM; REUSABLE INSTRUMENTS

Model Number 8361-10

Device Problem Arcing (2583)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue a with prestige grasper(s).During insulation testing in sterile processing department it was noticed the product was failing and causing an arc.Per the submission, this incident did not occur in surgery.Additional information has been requested to clarify that the arcing did not cause injury, and exactly how many instruments were involved.

Event Description

Clarification was received.It was confirmed that electrical testing had been performed, although the instructions for use (ifu) specifically state otherwise: "the prestige endoscopic instruments are not electrical instruments.Do not perform electrical testing on the instruments or the kynar coating may be damaged.".

Manufacturer Narrative

B 5: update received.D section: material# updated.The supplier, micro-stamping, has been notified and is aware that the instrument may have been damaged during testing.The customer facility was re-instructed on guidelines for use and processing of the device.

Manufacturer Narrative

D4- udi added upon evaluation of a similar device by aesculap technical services (ats), the following was observed: visual examination showed that the insulation on the shaft of the device had been damaged.Root cause there was no evidence of a mis-repair.It can be assumed that it was caused by transportation or improper handling.The endocsopic instruments are not electrical instruments, and electrical testing may damage the kynar coating.According to the instructions for use (ifu): inadvertent contact with an activated electrosurgical device may result in injury to the patient or surgeon.This warning is in place because the device is not an electrosurgical device.Prestige graspers should be inspected for insulation damage before and after each use.If the coating becomes visually damaged due to normal wear and tear, it should be returned to aesculap for repair.Aesculap ifu is provided with the product and can be found on our website: www.Aesculapusa.Com/ifu.Although the actual device was not received and the failure mode could not be confirmed, the second product returned from the same facility exhibited the failure (as noted above).

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9356407
• MDR Text Key: 167624788
• Report Number: 2916714-2019-00124
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2021

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: 8361-10
• Device Catalogue Number: 8361-10
• Device Lot Number: M55797
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 08/10/2021
• Supplement Dates FDA Received: 03/30/2020; 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1