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

Model Number 8360-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a malfunction of a prestige grasper during surgery.The patient was undergoing an endoscopic procedure.This issue occurred while the grasper was being used to retract bowel; one of two jaw tips broke off and separated within the patient.Attempts were made to immediately remove the piece and about 30 minutes passed until it was retrieved.The jaw of the grasper was fully removed from the patient and it was confirmed that no serious injury or further intervention was required.It was noted that the prestige grasper had been used for a few weeks at the time of occurrence.

Manufacturer Narrative

Manufacturing site evaluation: investigation performed without return of product.Micro has communicated the issue to the personnel directly responsible for the part in order to increase awareness and decrease the risk of escapement while the team investigates the root cause.A lot number associated with the defect was not provided, and therefore containment details related to the shipment lot could not be performed.At the time of complaint, micro had no wip or finished good in inventory to review.A corrective action was not initiated due to the non-receipt of the device.The disposition of the complaint was based on evaluation of the complaint with respect to 2 criteria: severity and reoccurrence.The customer has reported 0 adverse impact to the patient or user that resulted in additional harm due to this non-conformance.While there were no adverse impacts to the patient or user, the disassembly of the jaws is considered to be a severe defect.We reviewed historical data and found that there were previous similar complaints within the last 2 years for the same part number for "not grasping" and "breaking apart".While this defect has been considered severe and there have been reoccurrances, micro has already opened an ncr.Based on the evaluation of the complaint against the criteria, micro has determined that documenting reference to the existing ncr will be sufficient to close out this complaint.In the event that the device is returned and micro determines the complaint is not the same as detailed in the ncr, the disposition decision will be re-evaluated.

Manufacturer Narrative

Additional investigation summary: as a result of an adverse trend for devices exhibiting failure at the thumb-loop assembly joint, a supplier corrective action request (scar) was initiated.The malfunction was evaluated by the supplier by looking at devices with a lot number beginning with "m." as a result of their findings, the push rod fixture was redesigned to increase the clearance, which ensured that the fixture appropriately stressed the entirety of the soldering joint.Upon implementing the new fixture, the supplier tested returned non-conforming samples, and verified that the soldering no longer hung up on the new fixture, as had been observed on the previous one.In addition to this scar, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.

• 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: 8122244
• MDR Text Key: 129042419
• Report Number: 2916714-2018-00041
• 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: 12/15/2020

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: 8360-10
• Device Catalogue Number: 8360-10
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/16/2019
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/01/2018
• Supplement Dates Manufacturer Received: 04/16/2019; 04/16/2019
• Supplement Dates FDA Received: 05/15/2019; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1