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

Model Number 8360-10

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.It was reported that one grasper came apart during a surgical procedure and the physician had to retrieve the lost piece.There was no harm to the patient.There was a five to ten minute surgical delay reported.

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.Supplier: (b)(4).Multiple attemtps for investigation results were made, not provided.At the time of the complaint, investigation of similar complaints for this failure mode have been completed by the original equipment manufacturer and determined the issue is related to excessive mechanical force.This file will be maintained for tracking and treding purposes.If investigation results become available in the future, this file will be re-opened and updated accordingly.Potential patient impact as a result of this product failure was addressed in a capa opened by aesculap.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley,, pa MA 01810
• MDR Report Key: 6545559
• MDR Text Key: 74488109
• Report Number: 2916714-2017-00004
• 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: 05/06/2020

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
• Device Lot Number: L50244654
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/04/2017
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 02/27/2017
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other