MAUDE Adverse Event Report: AESCULAP AG TC MAYO-HEGAR NDL HOLDERHVYSERR185MM; DUROGRIP NEEDLEHOLDERS

Model Number BM066R

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instruments are not available for investigation.Only photos are available for the investigation.The instruments were washed once and now show corrosion damaged.According to the available information, there were no negative consequences for patient.The photos showed found reddish-brown corrosion spots.The product does not require batch management; a review of the quality and manufacturing history records is not possible.The root cause of the problem is most probably reposing or maintenance related.According to the quality standard a material defect and production error can be excluded.The discoloration are pinprick-like corrosion holes surrounded by sparkling, reddish-brown or multi-colored corrosion spots, often associated with circular corrosion deposits around the corrosion hole.The following points could be the cause of this: exposure due to halide ions.Dried-on organic residues.Frequent pitting is due to the use of liquids.Brand new instruments are particularly layer.A capa is not necessary.

Event Description

Country of complaint: (b)(6).It was reported that there was corrosion after sterilization.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR185MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7691937
• MDR Text Key: 114297987
• Report Number: 9610612-2018-00286
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial
• Report Date: 07/16/2018

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: BM066R
• Device Catalogue Number: BM066R
• Device Lot Number: 4509344252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Distributor Facility Aware Date: 06/19/2018
• Device Age: 5 MO
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other