MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OBT_BUTTON_4.0,167CW_MITEK; RIGID ENDOSCOPE OBTURATOR

Model Number 242258

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported by sales rep that prior to an unknown surgery on (b)(6) 2021, it was observed that an obturator with button top device was stuck in the sheath and would not release.During in-house engineering evaluation, it was determined that an obturator was jammed inside the sheath.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: according to the information provided, it was reported that prior to an unknown surgery it was noticed that obturator with button top for 5.9mm sheath 167mm (mitek lock) is stuck in the dual stopcock sheath 5.9mm x 30 deg x 167mm (mitek lock); sheath will not release.The complaint device was received for evaluation.Upon visual inspection, it was found that the obturator is jammed inside the sheath.The obturator was reviewed, no structural anomalies were found.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The possible root cause for this issue can be attributed to the bent sheath end.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to damages on the sheath, however, this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: OBT_BUTTON_4.0,167CW_MITEK
• Type of Device: RIGID ENDOSCOPE OBTURATOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13010566
• MDR Text Key: 282630864
• Report Number: 1221934-2021-03755
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705029174
• UDI-Public: 10886705029174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242258
• Device Catalogue Number: 242258
• Device Lot Number: 1530729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1