MAUDE Adverse Event Report: AESCULAP AG RAMPLEY SPONGE FORCEPS STR SERR 180MM; BASIC INSTRUMENTS

Model Number BF116R

Device Problem Sharp Edges (4013)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the rampley sponge holders.Prior to use, the instruments were noted to have burrs on the serrations.The devices were not used in a procedure but were found during the quality check.Additional information was not provided.

Manufacturer Narrative

Manufacturing site evaluation: we received non-contaminated sponge forceps.The forceps are in mint condition in the original packaging.Investigation: the products were reviewed visually and microscopically.After viewing the products, the issue has been discussed with the responsible supplier quality manager.Due to the burrs found at the serrations of the working ends, the products are not according to the specifications.Batch history review: 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.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most likely related to a manufacturing error.Corrective action: the responsible quality coordinator of the production plant will be informed to evaluate the possibilities of corrective actions.

• Brand Name: RAMPLEY SPONGE FORCEPS STR SERR 180MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8709852
• MDR Text Key: 148408518
• Report Number: 9610612-2019-00393
• 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: 06/28/2019

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: BF116R
• Device Catalogue Number: BF116R
• Device Lot Number: 4509721094
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/05/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1