MAUDE Adverse Event Report: AESCULAP INC PRESTIGE RETR GRASPER SGL-ACT 5MM36CM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8361-00

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as no lot # was provided by the complainant.However, 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.Previous investigations performed against devices returned with distal braze failures identified improvement opportunities following a review of the tube sub assembly test procedure work instruction (wi), the brazing procedure wi, and the brazed joint buffing wi.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, based on prior evaluations of complaint devices reported with a failure mode of distal braze break/separation, this event likely occurred due to inadequacies in the defined production process which limited the device performance.Aesculap inc.Opened a corrective action/preventive action (capa) for further evaluation of the design transfer of this device.

Event Description

It was reported to aesculap inc.That there was an issue with prestige retr grasper sgl-act 5mm36cm (part #8361-00).According to the complainant,during an unspecified procedure, the device had a functional failure.The instrument had issue with jaws.There was no patient harm nor surgical delay.The malfunction is filed under aic reference xc (b)(4).

• Brand Name: PRESTIGE RETR GRASPER SGL-ACT 5MM36CM
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 12909853
• MDR Text Key: 282571587
• Report Number: 2916714-2021-00222
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083398
• UDI-Public: 4046955083398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8361-00
• Device Catalogue Number: 8361-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1