MAUDE Adverse Event Report: GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE

Model Number G27L-12A

Device Problems No Display/Image (1183); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.A visual inspection found the outer tube of the device bent.The object window was noted to have broken cover glass.The fiber optics of the device were found damaged resulting in no image.The customer¿s device is under repair.The instruction manual states in the ¿cautions ¿section ¿indicate that equipment may be damaged or may malfunction by misuse.¿.

Event Description

The service center was informed that during reprocessing, the device was noted to be bent and no device image was observed.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The content of this complaint was reviewed by the legal manufacturer (lm).The lm reported that the root cause of the event could not be conclusively determined.No abnormality on channels of the subject scope was detected, via the quality inspection report (qir).The lm recommends the customer refers to the instruction manual.-reprocessing manual) states to confirm the tip of a clean brush after use.It also states to retrieve the tip of the brush in case it was dropped in scopes.-ifu instruct to check residues and/or abnormalities by inserting endo therapy accessories to the channels during inspection prior to use.-we verified that performance of reprocessing been secured by conducting reprocessing in accordance with ifu.Therefore, the factor to cause of ¿cleaning brush tip found inside suction channel¿ is the tip remained in the channel.The cause of the event cannot be conclusively determined.There was no report on abnormality of the scope interior and a cleaning brush is consumables.Therefore, we presumed that deteriorated tip of the brush was broken and dropped into the scope.The cause of the tip of brush remained in the channel cannot be conclusively determined.Ifu instructs to confirm the tip of the brush after reprocessing.It also instructs to retrieve the tip in case it was dropped into the device.From above, the event was seemingly due to the user who did not conduct reprocess in accordance with ifu, and/or did not conduct inspection of the brush after reprocessing.The event is preventable by conducting reprocessing/inspection in accordance with ifu.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Type of Device: GYN OPERATIVE 12 DEGREE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10317259
• MDR Text Key: 202241495
• Report Number: 1519132-2020-00032
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K980972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G27L-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1