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

Model Number 8360-10

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.There was a lot of tension placed with the use of a grasping forceps, prestige forceps.In the process of doing this, one of the graspers slipped from the tissue under tension and with that, broke across the jaws of the instrument, one of the opposing jaws was no longer attached to the instrument.

Manufacturer Narrative

Actions taken by aesculap: a capa had been opened to address the failure mode of "tip break off, during surgery".Supplier: (b)(4) investigation results: the reported atraumatic d/a grasper intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the jaw broke off in the patient during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation could not identify any evidence of product contribution to the reported complaint.

Event Description

Clarification was received: the initial mdr had been prepared and submitted with information received via medwatch (b)(4).The original procedure being performed had been a laparoscopic ventral hernia mesh re-repair with lysis of adhesions.A second surgery had been required for device fragment retrieval.Further information had been requested and it was confirmed that all available details had been provided.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: ENDOSCOPY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa MA 01810
• MDR Report Key: 7028683
• MDR Text Key: 92672931
• Report Number: 2916714-2017-00024
• 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
• Report Date: 06/10/2020

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: L50489069
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2017
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 08/10/2019
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention