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

Model Number G27L-30WA

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center followed up with the user facility to obtain additional information regarding the reported event but with no result.The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and found the scope in two pieces.The shaft is broken at the proximal end, near the main body.There are light scratches at the base of the shaft, and the light guidepost as well.The breakage point on each of the separate pieces is rough, and slightly sharp.There are no missing pieces from the damaged shaft.Additionally, the image is very unclear, likely caused by the damage to the shaft.There was no patient involvement.Based on the evaluation, the likely cause of the broken shaft is due to mishandling caused by excessive force.No additional information was made available at this time.The instruction manual states ¿inspect the entire surface of the scope for dents, protrusions, or other irregularities.Feel the entire shaft with fingers, checking for irregularities.Do not use if damage is found.¿.

Event Description

Olympus was notified by a user facility that during re-processing, the shaft broke off.The scope was in two pieces.There was no patient injury reported at this time.No additional information has been provided at this time.

• 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: 10125758
• MDR Text Key: 194623640
• Report Number: 1519132-2020-00009
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 05/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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