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

Model Number 8360-10

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

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.

Event Description

It was reported there was an issue with the grasper.The reporter indicated that during a laparoscopic cholecystectomy procedure, when the surgeon was using the laparoscopic grasper it broke.The hinge separated from instrument and was able to be retrieved.Per the reporter, no excessive pressure was added to the device.Just the spring came off; the spring was easily retrieved from the surgical site, x-ray was taken to ensure no retained pieces (may have completed x-ray as normal part of procedure, however, it is not sure).Delay was minimal while the spring was retrieved.No patient injury.Intervention: successful retrieval with x-ray.

Manufacturer Narrative

Investigation results: one grasper was returned for evaluation.Visual assessment of the device confirmed the reported complaint of disassembly.The dual action links have come free from the assembly.Only one of the two links were returned for evaluation.The returned link is well worn were it interfaces with the actuator.Shrink tubing has been applied to the sheath.The sheath is also slightly bowed.The device has been repaired as the handle has been bead blasted and has had additional etching (aes 10/16, s) added.The devices jaws have not been finished properly during the repair as they have multiple sharp edges that could cause injury during use.The condition of the device indicates the repair of the device likely contributed to the reported failure.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9953864
• MDR Text Key: 187800505
• Report Number: 2916714-2020-00087
• 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
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: 50244650
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention