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

Model Number 8360-10

Device Problem Material Fragmentation (1261)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.It was reported that a (b)(6) female came back after lap surgery with abdominal pain.During exploratory surgery in (b)(6), it was noted that a metal fragment was recovered.The fragment is believed to be a piece of a 8360-10.(the fragment is not the jaw but believed to be the mechanism between the jaw and the insulation.) patient went home next day.

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.B1 - serious injury updated.B5- updated description.Actions taken by aesculap: a capa had been opened to address the failure mode of "tip break off, during surgery".Supplier: (b)(4).(note: possible lot number identified) investigation results - our reference no.: (b)(4).External reference: (b)(4).Part name: grspr d/a atraumatic 5mmx36cm part no.: 8360-10 serial no.: lot no.: 50592123 description of complaint: it was reported that the device broke during surgery and stays in patient.Surgery was made to remove the metal piece.Investigation results: due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.

Event Description

Clarification was received: the original date of surgery was (b)(6) 2017.It was noted that possibly 1 of 3 graspers were used in the initial surgery, and it was unknown as to which one.All 3 were visually inspected at the facility by the risk management staff.

• 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: 6795448
• MDR Text Key: 82774408
• Report Number: 2916714-2017-00018
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Distributor Facility Aware Date: 08/10/2017
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR