MAUDE Adverse Event Report: AESCULAP AG GILLIES TISSUE FORCEPS DEL 1X2 155MM; BASIC INSTRUMENTS

Model Number BD660R

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site 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 bd660r - gillies tissue forceps del 1x2 155mm.According to the complaint description, burrs and fragments on serrations are detected during incoming goods inspection.There was no described patient harm because no patient was involved.Additional information was not provided.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: GILLIES TISSUE FORCEPS DEL 1X2 155MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11497147
• MDR Text Key: 253215566
• Report Number: 9610612-2021-00185
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 04038653024117
• UDI-Public: 4038653024117
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

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: BD660R
• Device Catalogue Number: BD660R
• Device Lot Number: 52656242
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1