MAUDE Adverse Event Report: GYRUS ACMI, INC SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE

Model Number GY275L-B

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation found that the sheath outer tube was observed to be dented and damaged tip with sharp edges were noted.The reported issue was confirmed.The physical damage to the device can be attributed to user mishandling.Per the (instruction for use), the ifu for gy275l-series (99-1044 _ej) provides warnings and cautions to alert that the device may be damaged by improper handling.It states "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.

Event Description

During reprocessing, it was reported that the tip was damaged.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide the event date and additional information based on the legal manufacturer¿s final investigation.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

• Brand Name: SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE
• Type of Device: SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11303794
• MDR Text Key: 280447671
• Report Number: 1519132-2021-00004
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925001787
• UDI-Public: 00821925001787
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GY275L-B
• Device Lot Number: RXJS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1