MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP; HEMOSTAT

Model Number MB229R

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Event Description

Per the report, a curved mosquito clamp tip broke during surgery (right hand, fifth metacarpal).Per the attending surgeon, mini-c-arms confirmed no particles/pieces in the patient, and all pieces removed per attending surgeon: the broken piece and the mosquito were sent to central for proper disposition.

• Brand Name: AESCULAP
• Type of Device: HEMOSTAT
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 16843412
• MDR Text Key: 314307154
• Report Number: 16843412
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MB229R
• Device Catalogue Number: MB229R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic