MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Model Number 261221

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has ben initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a codman disposable perforator (261221) was disassembled during surgery.All parts that fell into the surgical field were collected.Based on information provided, it is unknown if there was patient injury.No further information available.

Manufacturer Narrative

Codman disposable perforator was returned for evaluation.Device history record (dhr)- product 261221 with lot 5804671 was reviewed and there is an indication that the production process may have contributed to this complaint.All test results passed procedural specifications, however the 19 units scrapped at the welding step during production indicates that the manufacturing process could have contributed to the complaint condition.Failure analysis- the perforator unit was inspected using the unaided eye: unit was lightly soiled, and received disassembled, there was a shallow weld on the blue sleeve.Ifu testing procedure was performed with no observed anomalies once reassembled with the original parts the unit was returned with.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to not perform as intended with the original parts it was manufactured with, the unit plunged during testing and disassembled.The device was reassembled with a new sleeve, and then performed as intended.Root cause - the complaint was confirmed in the complaint investigation.The device did not function as was intended with the original parts it was manufactured with, and performed as intended once reassembled with new parts.The dhr review also concluded that there were 19 units scrapped in production during the welding step, and due to this, it is possible that the manufacturing process could have contributed to the complaint condition.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14687826
• MDR Text Key: 294676220
• Report Number: 3014334038-2022-00123
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 5804671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1