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

Model Number 8360-10

Device Problem Solder Joint Fracture (2324)

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

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.

Event Description

Clarification: this was confirmed to be a duplicate report.

Manufacturer Narrative

B5: update.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.

• Brand Name: PRESTIGE ATRA GRASPER DBL-ACT 5MM
• Type of Device: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa PA 18034
• MDR Report Key: 9286732
• MDR Text Key: 165408564
• Report Number: 2916714-2019-00113
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

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
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1