MAUDE Adverse Event Report: AESCULAP AG CARBON STEEL SCALPEL BLADES #23 BASIC INSTRUMENTS

Model Number BB523

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Manufacturing site evaluation: one box was received with 98 pieces within the dispenser; they were in a decontaminated condition. Failure description - of the 98, 70 packages were damaged and 28 were undamaged. Investigation: visual inspection showed damaged dispenser packaging, and some of the blades protruded through the individual packs. Batch history review: the device quality and manufacturing history records have been checked for the lot numbers and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: the root cause of the problem is most likely related to an improper transport of the product. Rationale: according to the quality standard and history records, a material defect and production error can be excluded. Investigations lead to the assumption that the visibly damaged dispenser packages were caused due to an improper transport of the product. There is also the possibility that the cause could be traced back to an increased load, e. G. Drops, impacts, or similar, during transport. A capa was initiated and completed.

Event Description

It was reported that there was an issue with the surgical blades within the dispenser. This occurred preoperatively and there was no patient harm. The box/dispenser with individual packs was noted to have damaged packaging inside of it and some of the blade tips protruded. The box was removed and not used. Additional information was not provided.

• Brand Name: CARBON STEEL SCALPEL BLADES #23
• Type of Device: BASIC 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8693076
• MDR Text Key: 147860057
• Report Number: 9610612-2019-00361
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BB523
• Device Catalogue Number: BB523
• Device Lot Number: 4509140958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 05/27/2019
• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial