MAUDE Adverse Event Report: AESCULAP AG & CO. KG HALSTED-MOSQUITO FCPSDELSTR1X2125MM; VASCULAR CLAMP

Model Number BH120R

Device Problem Break (1069)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint: the mouse tooth of the jaw was missing.When the surgeon tried to use this product in surgery, e found that the mouse tooth of the jaw was missing.The fragment has not been found yet.Primary surgery: (b)(6) 2014.Revision surgery: none.Pt data: unk.Further detail: none.Involved component: none.Reason for vigilance suspicious: fragment has not been found.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Mfg site evaluation: the issue has been caused by a mfg error, which was not detected in final inspection.All responsible personnel have been informed regarding this issue in order to ensure it is avoided in the future.No further action required.

• Brand Name: HALSTED-MOSQUITO FCPSDELSTR1X2125MM
• Type of Device: VASCULAR CLAMP
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 7853 2
• Manufacturer (Section G): AESCULAP AG & 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: 4120804
• MDR Text Key: 18369493
• Report Number: 2916714-2014-00583
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

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: BH120R
• Device Catalogue Number: BH120R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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