MAUDE Adverse Event Report: AESCULAP AG AND CO. KG UNIVERSAL WIRE CUTTERS 160MM

Model Number DP505R

Device Problem Break (1069)

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

Event Date 10/10/2014

Event Type  malfunction  

Event Description

During surgery, handle snapped off.No pt injuries reported, report of prolonged surgery, length of delay unk at time of this report.

Manufacturer Narrative

Mfg site eval: eval on-going at mfg site.

• Brand Name: UNIVERSAL WIRE CUTTERS 160MM
• Type of Device: WIRE CUTTERS
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4270128
• MDR Text Key: 5297830
• Report Number: 2916714-2014-00814
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

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: DP505R
• Device Catalogue Number: DP505R
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other