MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI HANDLE BATTERIES PACK OF 1; LARYNGOSCOPE, RIGID

Catalog Number 005853300

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "one of the batteries was installed today but it does not work".The issue was detected prior to patient use.There was no patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 005853300 rusch mri handle batteries (pack of 1) for investigation.Visual examination did not reveal any obvious defects or anomalies.Functional inspection was performed by inserting the battery into a known good lab inventory mri laryngoscope handle and attaching a known good lab inventory blade onto the handle.The led did not energize.It appears that the contact bin on the battery was deformed and flattened, which prevented the battery from making contact with the handle to form a closed continuous circuit.Once the contact pin was adjusted to make proper contact with the handle, the led energized and the device functioned properly.The damage observed indicates that the contact pin became deformed during battery insertion into the handle.It appears that unintentional user error caused or contributed to this event.The battery voltage was measured to be 3.126 v dc which is consistent with the nominal voltage.The device history record of lot 190701 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The complaint is confirmed.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "one of the batteries was installed today but it does not work".The issue was detected prior to patient use.There was no patient involvement reported.

• Brand Name: RUSCH MRI HANDLE BATTERIES PACK OF 1
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10840013
• MDR Text Key: 216335023
• Report Number: 8030121-2020-00152
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Catalogue Number: 005853300
• Device Lot Number: 191201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1