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

Model Number 8360-10

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with the prestige grasper.During a laparoscopic colorectal procedure, the tip of the jaws broke off inside the patient.The tip and spacer were retrieved using another instrument.There was no harm to the patient or intervention, but there was a 10-20 minute surgical delay noted due to the removal.Additional information was not provided.

Manufacturer Narrative

The samples that were provided were sent to the manufacturing site for evaluation.Results of the investigation show that the root cause for the thumb-loop welding assembly was determined to be related to inconsistencies in the manufacturing process at the welding area for lots beginning with an "m".As a result, these complaints have been confirmed by the aesculap qa team.The investigation is still on-going for the distal jaw assembly; however, we have received the devices and can confirm these product failures, at this time.Furthermore, aesculap has identified the product potentially affected by these issues and is working with the manufacturer of these devices to institute appropriate corrective actions and control measures to detect and prevent this issue from recurring.

Manufacturer Narrative

The samples that were provided were sent to the manufacturing site for evaluation.Results of the investigation show that the root cause for the thumb-loop welding assembly was determined to be related to inconsistencies in the manufacturing process at the welding area for lots beginning with an "m".As a result, these complaints have been confirmed by the aesculap qa team.The investigation is still on-going for the distal jaw assembly; however, we have received the devices and can confirm these product failures, at this time.Furthermore, aesculap has identified the product potentially affected by these issues and is working with the manufacturer of these devices to institute appropriate corrective actions and control measures to detect and prevent this issue from recurring.

Manufacturer Narrative

In sec g6 instead of follow up # 2, we used follow up # 3.For follow up # 2 we are getting unknown duplicate report error while submitting.Investigation results: during a retrospective review, this complaint was re-assessed and found to be a malfunction as well as serious injury due to the additional medical intervention required.The product was reported to have a distal tip failure during a procedure along with removal of the piece.The device was not available for evaluation by the manufacturer.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Additionally, historical scrap rates were reviewed with no increase observed in scrap related to the complaint issue.The supplier reviewed the work instructions (wi) for the tube sub assembly test procedure wi, the brazing procedure wi, and the brazed joint buffing wi and identified improvement opportunities.While the tube subassembly joint is 100% percent tested with a torsional force, there was no requirement for applying a bending force to the joint.Therefore, a manual bend test was added to the wi.Additionally, a review of the torque test fixture and accompanying wi, noted the potential for the tube to slip inside the collet during inspections allowing for a defective part to potentially pass this test.The tube sub assembly test procedure was further updated to note this potential failure mode and to define the process for cleaning the parts and fixture/collet with alcohol prior to use.A review of the brazing procedure wi revealed that the glass tube was too short to effectively seal the brazing area off from the surrounding environment.Without a proper seal the brazing area could have insufficient argon present to facilitate effective brazing.The brazing procedure wi was updated to include a check for this condition prior to brazing.Additionally, the supplier updated the wi to optimize the order of operations of when flux is applied, the soldering ring is assembled, and the tube is loaded.This change ensured that flux would be present throughout the entire joint space and allow for proper solder travel.Furthermore, a functional review and visual examination of the nest, which the tube sub assembly sits into, was performed.This review revealed that the two argon access holes were clogged.Therefore, the associated preventative maintenance activities were updated to monitor the access holes and prevent a recurrence of buildup.Finally, the supplier updated the brazed joint buffing wi to note the potential failure mode of excessive buffing, which could remove too much material and weaken the joint.The investigation into the cause of the reported problem was unable to confirm the failure mode of a distal braze failure/breakage due to lack of product return.However, the product family has been shown to have distal weld issues (above).This event likely occurred due to use of excessive force or inadequacies in the defined production process which limited the device performance.Therefore, the most probable root cause is considered to be manufacturing related.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.

• 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: 9105466
• MDR Text Key: 159760393
• Report Number: 2916714-2019-00059
• 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,Followup
• Report Date: 08/04/2021

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
• Device Lot Number: L50429911
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 10/03/2019; 07/27/2021
• Supplement Dates FDA Received: 10/30/2019; 10/30/2019; 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention