MAUDE Adverse Event Report: AESCULAP INC. PRESTIGE ATRA GRASPER DBL-ACT 5MM; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number 8360-10

Device Problems Break (1069); Solder Joint Fracture (2324)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2019

Event Type  malfunction  

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 prestige graspers.The graspers were broken at the weld.The facility noted that this puts a strain on remaining instrument sets.There was no patient harm or intervention required.The incident occurred in surgery (to be confirmed).Additional information was not provided.Associated medwatches: 5 instruments reported separately.

Manufacturer Narrative

Several complaints and mdrs had been created due to the original reported issue; 3 cases were closed as duplicates, and 2 mdr follow-ups will be submitted with clarification.Originally reported malfunction: broken at weld.

Event Description

Clarification was received: sales consultant confirmed that all graspers were noted to be malfunctioning in sterile processing - that there was no patient involvement.

Manufacturer Narrative

B5: update.The malfunction has been investigated by the supplier, micro-stamping, and a corrective action was performed.Aesculap inc.Had opened a capa to follow this issue.Aesculap inc.Initially found that there was lack of flow of solder at weld, and broken soldering between the rotator housing and thumbloop.Micro-stamping evaluated multiple batch # starting with m.Micro-stamping re-designed the push rod fixture, increasing the clearance, to ensure that the fixture is appropriately stressing the entire soldering joint.Upon implementing the new fixture, it was verified that the new fixture does not hang up on the soldering as the old one did when testing a returned non-conforming sample.Associated medwatches: 400448614 (2916714-2019-00110); 400450717 ( 2916714-2019-00111); 400450718 ( 2916714-2019-00112)- duplicate; 400450719 ( 2916714-2019-00113) -duplicate; 400450725 (2916714-2019-00114) -duplicate.

Event Description

Clarification: the reported malfunction, weld broken, was found to have occurred in sterile processing and not in a surgery.

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 conducted by the manufacturer for the lot # of the device in question.No non-conformances were reported.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.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/proximal weld failure/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

No update required.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• 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 ; 6109849072
• MDR Report Key: 9286729
• MDR Text Key: 165407044
• Report Number: 2916714-2019-00110
• Device Sequence Number: 1
• Product Code: NWV
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/15/2021

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: M48115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 10/25/2019; 11/02/2021
• Supplement Dates FDA Received: 11/23/2019; 03/25/2020; 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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