MAUDE Adverse Event Report: AESCULAP INC PRESTIGE RETR GRASPER DBL-ACT 5MM; LAPAROSCOPIC

Model Number 8361-10

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: height cm: 190.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "during a laparoscopic appendectomy procedure the tip of the device broke apart in four different pieces while performing the surgery." this incident did not cause or contribute to serious injury or death or a delay in surgery.The pieces fell into the patients, but the pieces were removed.

Manufacturer Narrative

Evaluation - at the time of receiving the complaint there were no device lot #m45399 in inventory.The complained product was received.Root cause analysis - micro also reviewed historical non-conformances and found that there were previous similar complaints within the last twenty-four (24) months from the date of this complaint for not grasping and breaking apart.Due to the non receipt of the devices back from aesculap a desposition decision was not made at the time.Non-conformance related to method - root cause was determined to be related to the brazing process.Action plan - further investigation will be documented in a corrective action, as requested by aesculap.(car 1930046 supplier micro-stamping).

Manufacturer Narrative

Correction - incorrect lot # mentioned in previous evaluation, with reference to a corrective action.Evaluation - at this time, there were no devices with the same lot# in inventory (m45171).Root cause analysis and verification - through our investigative analysis, we tried to disassemble a device through normal use, but it would not.We reassembled the original device, and through trip testing, the device still would not disassemble.Only through intentional misuse of a new device did it disassemble in a similar fashion to thecomplaint part.Due to our inability through testing to recreate the failure mode, theis analysis is inconclusive.Only through intentional misuse of a new device would it disassemble.

• Brand Name: PRESTIGE RETR GRASPER DBL-ACT 5MM
• Type of Device: LAPAROSCOPIC
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8404884
• MDR Text Key: 138271967
• Report Number: 2916714-2019-00005
• 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,Followup
• Report Date: 01/30/2020

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: 8361-10
• Device Catalogue Number: 8361-10
• Device Lot Number: M45171
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/12/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 06/17/2019; 01/30/2020
• Supplement Dates FDA Received: 11/01/2019; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84