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

Model Number 8360-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The complainant reported to aesculap, inc that a prestige atra grasper dbl-act 5mm device was used during a laparoscopic cholecystectomy procedure performed on (b)(6) 2020.During the procedure, the device jaws broke and detached into the patient.The jaw fragment was retrieved, and then an x-ray was performed to confirm that no fragments remained within the patient.Although a slight surgical delay was noted, no patient complications were reported as a result of the event.The device is available to be returned to the manufacturer for investigation.

Manufacturer Narrative

Our reference number: (b)(4).(b)(4).Investigation results: one 8360-10, 5mmx36cm atraumatic dual action grasper device used in treatments, was returned for evaluation.This is an eight year old reusable instrument.A paddle was missing, and not with the return.Scissor action functioning still activated the remaining paddle.There was slight wear on fulcrum which may have allowed paddle to become free from the jaw.The distal kynar sheathing was slightly worn.There was no absent or broken weld observed at the rotational hub.Relationship between the event and device was not fully confirmed.Per instructions for use aesculap prestige endoscopic graspers aesculap endoscopic graspers are designed to be used through a cannula, or port, commonly called a trocar sleeve and are designed to grasp soft tissue structures during endoscopic procedures.Any use of an instrument for a task other than its intended purpose will usually result in a damaged or broken instrument.Lateral pressure on the instrument when inserting or removing it may damage the shaft working tip.Instruments must be handled carefully during surgery and cleaning to avoid misusing the instrument.Misuse will usually result in damage or breakage.It is unknown whether a service and maintenance plan was followed.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Product met specifications upon release to distribution.No further action required at this time.

• 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
• MDR Report Key: 10507942
• MDR Text Key: 206298947
• Report Number: 2916714-2020-00405
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 04046955083374
• UDI-Public: 4046955083374
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Lot Number: L50431623
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention