MAUDE Adverse Event Report: AESCULAP AG ADSON TS FCPS FEN-HDL SER 1X2T.120MM; FORCEPS

Model Number BD512R

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that during a skin graft procedure, the tooth of a forcep was found to be damaged and missing.Staff at the facility were not sure if the damage occurred during reprocessing of the device or if the device broke during the procedure.There were unable to locate any broken piece(s) during the operation.It has been indicated that there is potential for the patient to have a retained piece.It is unknown if x-rays were taken.Additional information has been requested however, not yet received.

Manufacturer Narrative

Investigation: the investigation was carried out visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found a broken off tooth.Additionally we found a worn gripping surface.Furthermore we made a visual inspection of the fracture surface.Here we found unknown impurities.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.One similar incident has been filed with a product from the same batch (cc 400405435) conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: according to the quality standard and dhr files, a material defect and production error can be excluded.No pores or foreign bodies could be found on the point of rupture.Investigations lead to the assumption that the breakage was caused by an improper handling due to a mechanical overload situation.This is also confirmed by the worn gripping surface.No capa is necessary.

• Brand Name: ADSON TS FCPS FEN-HDL SER 1X2T.120MM
• Type of Device: FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• MDR Report Key: 7924408
• MDR Text Key: 122308239
• Report Number: 9610612-2018-00451
• Device Sequence Number: 1
• Product Code: HTD
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BD512R
• Device Catalogue Number: BD512R
• Device Lot Number: 4508273705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Distributor Facility Aware Date: 09/28/2018
• Device Age: 20 MO
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1