MAUDE Adverse Event Report: GYRUS ACMI, INC 2.7MM LONG GYN TELESCOPE

Model Number G27L-30WA

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint was confirmed.A visual inspection was performed on the returned device and found the outer tube broken in half.The device¿s e/p window unit and funnel cup were inspected which noted debris underneath the cover glass on eyecup.The optical fibers were also, inspected and no image was observed.The device was repaired and returned to the customer.The instruction manual states ¿examine the scope for optical clarity by looking through the lens while viewing a white paper with writing, held about 1 cm from the distal tip of the scope.Check that the visual field is clear.If necessary, clean the outside of the proximal and distal lenses with a protein-dissolving cleaner and then wipe with a lint-free applicator saturated with 70% isopropyl alcohol.¿.

Event Description

The user facility reported that during preparations for use the lens was noted to be brownish yellow and makes it dark when trying to see.There was no patient involvement reported.

• Brand Name: 2.7MM LONG GYN TELESCOPE
• Type of Device: 2.7MM LONG GYN TELESCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10160029
• MDR Text Key: 196448099
• Report Number: 1519132-2020-00018
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G27L-30WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1