MAUDE Adverse Event Report: AESCULAP AG BLOHMKE TONSIL SEIZING FORCEPS 205MM; GENERAL SURGICAL INSTRUMENTS

Model Number OM617R

Device Problem Material Fragmentation (1261)

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

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the clamp is in a used condition and is broken apart due to the broken locking screw.The screw head is not available for investigation.The mouth part doesn't show any damages on the teeth.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The lower part of screw is not completely in the thread and therefore not even to the shank.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.According to our investigation results the breakage of the screw is most probably related to a heavy torsion to the screw.Such a heavy torsion can be caused by a overtightening of the screw.As the lower part of the screw is not anymore even to the shank, we assume that the screw has been re-tightened afterwards to the delivery of the product to the customer.

Event Description

It was reported that there was an issue with the product blohmke tonsil seizing forceps 205 mm.Intraoperatively the instrument was about to be used to grasp soft tissue, when the screw came off and fell into the patients mouth.The screw could be removed successfully.No harm to patient reported.The malfunction is filed under aag reference (b)(4).

• Brand Name: BLOHMKE TONSIL SEIZING FORCEPS 205MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8915767
• MDR Text Key: 155864825
• Report Number: 9610612-2019-00544
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM617R
• Device Catalogue Number: OM617R
• Device Lot Number: 4510130995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1