MAUDE Adverse Event Report: GYRUS ACMI, INC. SLIMLINE; FORCEPS, BIOPSY, NON-ELECTRIC

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 01/15/2018

Event Type  malfunction  

Event Description

After cleaning from a case the tech found the alligator forcep had 1/2 of the jaw/mouth had broken off.Staff immediately informed the operating room of the problem.Unsure of when the instrument actually broke (during case, wash cycle, ect).Due to the size of the instrument, staff unable to locate the missing pieces.

• Brand Name: SLIMLINE
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 7218276
• MDR Text Key: 98220207
• Report Number: 7218276
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: GYA-5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NOT APPLICABLE.