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

Model Number	BD660R
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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
• Common Device Name: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11497147
• Report Number: 9610612-2021-00185
• Device Sequence Number: 11886451
• Product Code: HTD
• UDI-Device Identifier: 04038653024117
• UDI-Public: 4038653024117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: BD660R
• Device Catalogue Number: BD660R
• Device Lot Number: 52656242
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1